Page last updated: 2024-12-09

picibanil

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

Picibanil: A lyophilized preparation of a low-virulence strain (SU) of Streptococcus pyogenes (S. hemolyticus), inactivated by heating with penicillin G. It has been proposed as a noncytotoxic antineoplastic agent because of its immune system-stimulating activity. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID640429
CHEBI ID51354
MeSH IDM0016834

Synonyms (26)

Synonym
(2s,5r,6r)-3,3-dimethyl-7-oxo-6-[(phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
benzylpenicillin(1-)
2,2-dimethyl-6beta-(phenylacetamido)penam-3alpha-carboxylate
CHEBI:51354
picibanil
ccris 2776
ok 432
AB00384263
NCGC00021679-04
NCGC00021679-03
(2s,5r,6r)-3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
ok-432
39325-01-4
2f42bh7x2l ,
unii-2f42bh7x2l
sapylin
bdbm50377930
potassium;(2s,5r,6r)-3,3-dimethyl-7-oxidanylidene-6-(2-phenylethanoylamino)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
potassium;(2s,5r,6r)-3,3-dimethyl-7-oxo-6-[(1-oxo-2-phenylethyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
bdbm37632
potassium;(2s,5r,6r)-7-keto-3,3-dimethyl-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
cid_23664709
AB00053517_15
AB00053517_16
DTXSID00192555
Q27122556

Research Excerpts

Overview

Picibanil (OK-432) is a sclerosing agent derived from a low-virulence strain of Streptococcus pyogenes. It induces regression of macrocystic lymphangiomas.

ExcerptReferenceRelevance
"Picibanil (OK-432) is a sclerosing agent derived from a low-virulence strain of Streptococcus pyogenes that induces regression of macrocystic lymphangiomas. "( Treatment of lymphangiomas in children: an update of Picibanil (OK-432) sclerotherapy.
Bauman, NM; Burke, DK; Greinwald, JH; Kimura, K; Poust, RI; Sato, Y; Smith, RJ, 1999
)
2

Toxicity

ExcerptReferenceRelevance
" Findings were as follow: 1) Administration of beta-type Interferon for 2 days, following the administration of a toxic dose (140 mg/kg/w) of 5-FU, revealed significant protection from mortality in C3H/He mice."( [Prevention of 5-FU induced toxicity in C3 H/HE mice with interferon or with interferon inducers (poly 1: C, OK-432, Lentinan)].
Abe, R; Akimoto, M; Ewasaki, H; Kasai, M; Matano, S; Nakajima, Y; Ueki, H, 1984
)
0.27
" Intralesional injection of OK-432 was safe and effective therapy for cystic hygroma in this newborn as its inflammatory reaction was localised."( Efficacy and safety of OK-432 sclerotherapy for giant cystic hygroma in a newborn.
Boddy, SA; McCarthy, L; Samuel, M,
)
0.13
" The aim of this study is to establish the safe dosage of OK-432 in the intrauterine treatment of fetal cystic hygroma."( Experimental study concerning safety dosage of OK-432 for intrauterine treatment.
Ogita, K; Suita, S; Taguchi, T, 2006
)
0.33
" Major adverse effects related to therapy occurred in 11 patients."( Efficacy and safety of OK-432 immunotherapy of lymphatic malformations.
Bauman, NM; Burke, DK; Sato, Y; Smith, MC; Smith, RJ; Zimmerman, MB, 2009
)
0.35

Compound-Compound Interactions

Short-term intensive chemotherapy (STIC) consisting of large dose of mitomycin C (MMC), tegafur (FT-207), streptococcus preparation picibanil (OK-432) and Krestin (PSK), combined with IVH was performed in 72 patients.

ExcerptReferenceRelevance
"The present study was designed to evaluate the effect of rTNF alone or in combination with other BRMs on human digestive organ cancers."( In vivo effects of human recombinant tumor necrosis factor alone and in combination with other biological response modifiers on human digestive organ cancer xenografts transplanted in nude mice.
Fukumoto, M; Kawabata, K; Masai, Y; Morimoto, H; Nio, Y; Shiraishi, T; Tobe, T; Tseng, CC; Tsubono, M; Tun, T, 1991
)
0.28
" These results suggest that an appropriate immunostimulation combined with radiotherapy may be important for the suppression of tumor metastases."( [Modification of spontaneous lung metastasis by local radiation combined with or without immunomodifier].
Shigematsu, N, 1990
)
0.28
" During the past eleven years, we have used postoperative chemotherapy in three ways over three different periods: in the earliest period, short-term combined chemotherapy (STCC) was used, in the middle period, intermittent long-term combined chemotherapy (ILTCC) was used in combination with immunotherapy for a randomized group, and in the latest period, when continuous long-term combined chemotherapy (CLTCC) with immunotherapy was employed."( [Clinical value of postoperative chemotherapy for non-small cell lung cancer--with special reference to long-term combined chemotherapy combined with immunotherapy].
Hashizume, Y; Ichihashi, T; Iida, S; Kimoto, H; Kobayashi, H; Sato, H; Shimizu, J; Tsunamura, Y; Watanabe, Y; Yamada, T, 1985
)
0.27
" The protection of mice against HSV-1 infection and the production of neutralizing antibodies were significantly enhanced by the administration of LC 9018 in combination with inactivated HSV-1 antigen."( Protection of mice against herpes simplex virus infection by a Lactobacillus casei preparation (LC 9018) in combination with inactivated viral antigen.
Saito, H; Watanabe, T, 1986
)
0.27
"Thermotherapy combined with tegafur (FT-207) and Picibanil was performed in 13 patients with cancer of the urinary bladder."( [Thermotherapy for cancer of the urinary bladder in combination with tegafur suppository and picibanil--concentrations of tegafur in the serum and tissues in bladder carcinoma].
Arai, T; Honda, M; Kanbe, K; Kaneko, K; Maeda, S; Mukae, K; Murahashi, I; Sakuma, H; Tabata, Y; Takasaki, E, 1985
)
0.74
"A short-term intensive chemotherapy (STIC) consisting of large dose of mitomycin C (MMC), tegafur (FT-207), streptococcus preparation picibanil (OK-432) and Krestin (PSK), combined with IVH was performed in 72 patients with advanced gastric cancer."( [Short-term intensive chemotherapy (STIC) combined with intravenous hyperalimentation in advanced stomach cancer].
Hamazoe, R; Kanayama, H; Karino, T; Koga, S; Maeta, M; Oda, M; Osaki, Y; Shimizu, N; Yamane, T, 1983
)
0.47
"Thermotherapy combined with Tegafur and Picibanil was performed in 32 patients with cancer of the urinary bladder."( [Thermotherapy for cancer of the urinary bladder in combination with tegafur and picibanil--with special reference to the serum bladder and bladder cancer tissue concentrations of tegafur in a perfusion fluid].
Honda, M; Kanbe, K; Kaneko, K; Maeda, S; Murahashi, I; Takahashi, E, 1984
)
0.76
" The antileukemic action of AS 15557, alone or in combination with 5-FU, against L1210 leukemia was superior to that of a streptococcal preparation (OK-432) and was almost the same as of bacillus Calmette-Guérin with or without 5-FU."( Synergistic effects of Actinobacillus suis cells in combination with 5-fluorouracil on mice bearing murine L1210 leukemia cells.
Itoh, S; Watanabe, T, 1997
)
0.3
" For advanced gastric cancer, although gastric cancer cells are generally not very sensitive to most of the currently available chemotherapeutic agents, it has been reported that biochemical modulation with treatments including low-dose cisplatin + 5-FU (fluorouracil) have high response rates and exert an immunomodulatory effect especially when used in combination with BRMs."( Clinical potential of biological response modifiers combined with chemotherapy for gastric cancer. Japanese experience.
Andou, K; Fujisaki, S; Fukuzawa, M; Nezu, T; Shibata, M; Tomita, R, 2002
)
0.31
" HPL-PDT in combination with OK-432 topically administered 3 h before photo-irradiation is considered to be a promising therapeutic modality."( Hyperthermic photodynamic therapy combined with topical administration of OK-432 in the mouse carcinoma.
Inokuchi, T; Uehara, M, 2003
)
0.32
" Vaccination of syngeneic mice with fixed Hepa 1-6 cells in combination with OK-432 and tuberculin as an adjuvant resulted in a significant increase in survival of mice against live Hepa 1-6 cell challenge."( Protective antitumor immunity induced by fixed tumor cells in combination with adjuvant in a murine hepatoma model.
Huang, L; Ohno, T, 2003
)
0.32
" When OK-432 was combined with PGE(2), the CCR7 expression and migratory capacity of DCs were significantly improved without impairing other immuno-stimulatory functions."( Generation of mature dendritic cells fully capable of T helper type 1 polarization using OK-432 combined with prostaglandin E(2).
Kaiga, T; Konishi, J; Sato, M; Suzuki, T; Tahara, H; Takayama, T; Tanaka, H, 2003
)
0.32
" These findings suggest that the local DC therapy in combination with TS-1 and OK-432 may be a useful strategy for the treatment of solid tumors, and that TLR4 signaling is involved in the success of this therapy."( Anti-tumor effect of an intratumoral administration of dendritic cells in combination with TS-1, an oral fluoropyrimidine anti-cancer drug, and OK-432, a streptococcal immunopotentiator: involvement of toll-like receptor 4.
Ahmed, SU; Hiroshima, T; Kan, S; Moriya, Y; Ohue, H; Okamoto, M; Oshikawa, T; Ryoma, Y; Saito, M; Sasai, A; Sato, M; Tano, T,
)
0.13
" These findings suggest that local DC therapy in combination with TS-1 and OK-432 may well be a useful strategy for the treatment of solid tumors, and that TLR4 signaling is involved in the success of this therapy."( [Anti-tumor effect of intratumoral administration of dendritic cells in combination with TS-1 and OK-432].
Ahmed, SU; Okamoto, M; Oshikawa, T; Sato, M; Tano, T, 2004
)
0.32
" In this study, we investigated the antitumor effects and associated mechanisms of action that were induced by systemic and local immunization with a CTL-directed peptide in combination with a peritumoral injection of a streptococcal preparation, OK-432."( Antitumor effects of systemic and local immunization with a CTL-directed peptide in combination with a local injection of OK-432.
Harada, M; Itoh, K; Mine, T; Nakashima, T; Ono, T; Sakamoto, K; Takao, Y; Tanaka, M; Tanaka, Y; Yamada, A, 2006
)
0.33
" In combination with local control using RFA, we attempted a systemic immunotherapy using OK-432, by subcutaneous injection around RFA to accelerate host antitumor immune responses induced by antigen stimulation by RFA, based on the immunological property of the omentum."( [A case of immunotherapy using OK-432 in combination with RFA for CRT-resistant recurrent tumors of esophageal cancer that presented itself in the intramediastinal omentum of gastric tube].
Fujiwara, H; Hagiwara, A; Ichikawa, D; Kikuchi, S; Komatsu, S; Nakamura, Y; Ochiai, T; Okamoto, K; Otsuji, E; Sakakura, C; Sonoyama, T; Suchi, K; Ueda, Y; Yamagishi, H, 2006
)
0.33
" The purpose of this study was to evaluate the clinical curative effect of percutaneous sclerotherapy of massive venous malformations of the face and neck using fibrin glue combined with OK-432 and pingyangmycin."( Percutaneous sclerotherapy of massive venous malformations of the face and neck using fibrin glue combined with OK-432 and pingyangmycin.
Chai, Q; Chen, WL; Huang, ZQ; Zhang, DM, 2010
)
0.36
"Eighteen patients with massive venous malformations were treated with an injection of fibrin glue combined with OK-432 and pingyangmycin."( Percutaneous sclerotherapy of massive venous malformations of the face and neck using fibrin glue combined with OK-432 and pingyangmycin.
Chai, Q; Chen, WL; Huang, ZQ; Zhang, DM, 2010
)
0.36
"Percutaneous sclerotherapy using fibrin glue combined with OK-432 and pingyangmycin provided a simple, safe, and reliable alternative treatment for massive venous malformations."( Percutaneous sclerotherapy of massive venous malformations of the face and neck using fibrin glue combined with OK-432 and pingyangmycin.
Chai, Q; Chen, WL; Huang, ZQ; Zhang, DM, 2010
)
0.36
"The purpose of this study was to determine the appropriate conditions for percutaneous sclerotherapy of juvenile nasopharyngeal angiofibroma using fibrin glue combined with OK-432 and bleomycin."( Percutaneous sclerotherapy of juvenile nasopharyngeal angiofibroma using fibrin glue combined with OK-432 and bleomycin.
Chai, Q; Chen, WL; Huang, ZQ; Li, JS; Zhang, DM, 2010
)
0.36
" Here we review our experience of 13 patients with AVM of the facial soft tissues who were treated using percutaneous sclerotherapy with fibrin glue combined with OK-432 and bleomycin after embolisation."( Percutaneous sclerotherapy of arteriovenous malformations of the face using fibrin glue combined with OK-432 and bleomycin after embolisation.
Chen, WL; Huang, ZQ; Lin, ZY; Wang, YY; Zhao, XP, 2016
)
0.43
"WT1 peptide vaccine therapy combined with OK-432 appears to be relatively safe for children."( Feasibility and Immune Response of WT1 Peptide Vaccination in Combination with OK-432 for Paediatric Solid Tumors.
Higuchi, Y; Hirabayashi, K; Koido, S; Koya, T; Nakazawa, Y; Okamoto, M; Saito, S; Sano, K; Shimodaira, S; Sugiyama, H; Yanagisawa, R, 2018
)
0.48
" We aimed to investigate the safety and the feasibility of a vaccination with WT1 peptide-loaded dendritic cells (DCs) and OK-432 adjuvant combined with molecular targeted therapy or conventional chemotherapy."( Vaccination of Urological Cancer Patients With WT1 Peptide-Pulsed Dendritic Cells in Combination With Molecular Targeted Therapy or Conventional Chemotherapy Induces Immunological and Clinical Responses.
Miyashita, M; Ogasawara, M; Ota, S, 2018
)
0.48
"Against Meth A fibrosarcoma solid tumor system, L-MTP-PE showed slight but statistically significant elongation of survival days against 5-FU monotherapy in spite of its non-effect on tumor growth, when combined with 5-FU."( Effects of Liposome-Entrapped Muramyl Tripeptide Phosphatidylethanolamine (L-MTP-PE) on the Tumor Growth and Survival of Mice Bearing Syngeneic Tumor in Combination with a Chemotherapeutic or Immunomodulatory Agent.
Abe, S; Tanaka, M, 2022
)
0.72
" To solve this clinical problem, we proposed a new treatment strategy of OK-432 in combination with an anti-programmed cell death protein 1 (αPD-1) antibody for residual tumors after incomplete RFA (iRFA) of hepatocellular carcinoma (HCC)."( Synergistic effect of OK-432 in combination with an anti-PD-1 antibody for residual tumors after radiofrequency ablation of hepatocellular carcinoma.
Cao, Y; Chen, J; Kan, X; Liang, B; Liu, J; Sun, B; Sun, T; Zheng, C, 2023
)
0.91

Dosage Studied

ExcerptRelevanceReference
" The dosage was 250 mg/day for 5-FU continuously, 10 mg/week for MMC and 5 KE/week for OK-432, respectively."( [Three cases of effective hepatic arterial infusion with OK-432, mitomycin C and 5-fluorouracil in liver metastasis from gastric cancer].
Hamada, H; Mori, N; Nakajima, I; Nakamura, T; Nakamura, Y; Tanaka, A; Wada, T; Yasutomi, M, 1989
)
0.28
" Good effects were not obtained when dosage exceeded appropriate levels."( [Effect of modification of host immune activity on radiation therapy].
Tsuchiya, T, 1987
)
0.27
" Although average values of the skin reaction after dosing were slightly lower compared to those before dosing in group B, sensitization was effective."( [Study on the preoperative adjuvant therapy of cancer--relation between serum and tumor tissue levels of UFT and OK-432 after administration, and skin reactions to Su-polysaccharide (Su-Ps)].
Ishikawa, M; Kumazawa, H; Rei, S; Saito, H, 1987
)
0.27
" rMuTNF could also induce the priming state; however, the dose-response kinetics of the priming effect to produce endogenous TNF was different between rHuTNFs and rMuTNF-alpha, suggesting species specificity among rTNFs used."( TNF induces endogenous TNF in vivo: the basis of EET therapy as a combination of rTNF together with endogenous TNF.
Inagawa, H; Mizuno, D; Oshima, H; Soma, G, 1988
)
0.27
" (Group II) into the subcutaneously transpositioned spleen three times prior to dosing with D-galactosamine, survival rates were 100 and 87%, respectively."( Acute liver failure in rats inhibited by intrasplenic administration of OK-432.
Ezaki, T; Furuta, T; Inokuchi, K; Kanematsu, T; Matsumata, T; Sonoda, T; Sugimachi, K; Takenaka, K, 1986
)
0.27
" The maintenance dosage of OK-432, was 5 KE once a week and was continued for at least 2 years after surgical resection."( [Adjuvant immunochemotherapy with long-term OK-432 administration in colorectal cancer].
Kawahara, T; Kikkawa, N; Sasai, H, 1984
)
0.27
" Divided drug dosage resulted in stronger inhibition than single administration."( Suppression of Friend leukemia virus by Bacillus Calmette-Guérin and a streptococcal preparation, OK-432.
Iida, H; Sakurai, Y; Tsukagoshi, S; Tsuruo, T, 1980
)
0.26
"Establishment of optimal dosage of OK-432, a streptococcal preparation, was studied based on its skin test was studied."( [Skin reaction to OK-432 and its dosage for locoregional administration].
Funakoshi, M; Kawami, H; Miyahara, E; Noma, K; Sawamura, A; Takashima, I; Toge, T; Yamaguchi, Y, 1994
)
0.29
"A single dose of inactivated streptococci (OK-432) was injected into the popliteal lymph nodes of male CDF1 mice and its effects on popliteal, inguinal, and para-aortic lymph node cells and spleen cells were investigated and compared with the effects of subcutaneous injections of the same dosage of OK-432."( Enhancement of LAK-like activity and cytokine induction in regional lymph nodes and spleen cells of mice after intralymphnodal injection of OK-432, a killed streptococcal preparation.
Hagiwara, A; Okano, S; Ozaki, K; Sakakura, C; Sasaki, S; Sawai, S; Takahashi, T; Tsujimoto, H; Yamane, T, 1993
)
0.29
" Treatment with OK-432 reversed this deficit for interferon gamma (IFN gamma) production in a dose-dependent manner, and mitigated the inhibition for interleukin-1 (IL-1) across all dosage groups."( Phase IB trial of picibanil (OK-432) as an immunomodulator in patients with resected high-risk melanoma.
Donnelly, S; Herberman, RB; Kirkwood, JM; Whiteside, TL; Wilson, J, 1997
)
0.63
" It was found that a positive clinical response was observed in 37 of the 51 (73%) patients with the DTH-oriented approach, showing a significantly higher efficacy than traditional dosage methods using empirical doses (31/58, 53%) (p=0."( Locoregional immunotherapy of malignant ascites from gastric cancer using DTH-oriented doses of the streptococcal preparation OK-432: Treatment of Th1 dysfunction in the ascites microenvironment.
Hihara, J; Kawabuchi, Y; Miyahara, E; Noma, K; Ohshita, A; Toge, T; Yamaguchi, Y, 2004
)
0.32
" The aim of this study is to establish the safe dosage of OK-432 in the intrauterine treatment of fetal cystic hygroma."( Experimental study concerning safety dosage of OK-432 for intrauterine treatment.
Ogita, K; Suita, S; Taguchi, T, 2006
)
0.33
" Under the diagnosis of cardiac tamponade, we treated her with pericardial drainage and systemic chemotherapy (intravenous dosage of trastuzumab and vinorelbine: VNR), and then pericardial effusion disappeared."( [A case of carcinomatous cardiac tamponade caused by breast cancer treated with instillations of OK-432 and mitomycin C].
Fujita, M; Matsuura, O; Morohashi, H; Morohashi, S; Nishimura, A; Yakoshi, Y; Yamada, K; Yonaiyama, S, 2010
)
0.36
" Randomized clinical trials focused on OK-432, bleomycin, or alcoholic solution of zein; standardized dosing protocols; and consistent and reliable outcome reporting will be necessary for further development of treatment guidelines."( Sclerotherapy for lymphatic malformations in children: a scoping review.
Ali, A; Churchill, P; Flageole, H; Otal, D; Pemberton, J; Walton, JM, 2011
)
0.37
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
penicillinate anionAny anion formed by loss of a proton from the carboxy group of a penicillin.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (4)

PathwayProteinsCompounds
peptidoglycan maturation (meso-diaminopimelate containing)1641
superpathway of penicillin, cephalosporin and cephamycin biosynthesis1169
deacetylcephalosporin C biosynthesis444
penicillin G and penicillin V biosynthesis319

Bioassays (1)

Assay IDTitleYearJournalArticle
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,521)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990687 (45.17)18.7374
1990's411 (27.02)18.2507
2000's257 (16.90)29.6817
2010's149 (9.80)24.3611
2020's17 (1.12)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 39.34

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index39.34 (24.57)
Research Supply Index7.47 (2.92)
Research Growth Index4.25 (4.65)
Search Engine Demand Index63.12 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (39.34)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials149 (9.30%)5.53%
Reviews73 (4.56%)6.00%
Case Studies276 (17.23%)4.05%
Observational1 (0.06%)0.25%
Other1,103 (68.85%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (5)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 2, Multicenter, Open Label Study to Evaluate the Efficacy and Safety of OK-432 Immunotherapy in Individuals With Lymphatic Malformations [NCT03427619]Phase 2275 participants (Actual)Interventional2005-10-05Completed
Phase I/II Study on Intratumor Dendritic Cell Injection Immunotherapy Using Immature Dendritic Cells With S Pyogenes Preparation (OK-432) for Patients With Resectable Pancreatic Cancer [NCT00795977]Phase 1/Phase 220 participants (Anticipated)Interventional2003-11-30Active, not recruiting
Treatment of Cystic Hygroma (Lymphangiomas) in Children- Picibanil(OK432) Sclerotherapy-Multicenter Trial [NCT00010452]Phase 2/Phase 3150 participants (Actual)Interventional2000-04-30Completed
Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432 [NCT01699347]Phase 45 participants (Anticipated)Interventional2012-09-30Recruiting
The Efficacy of OK-432 Pleurodesis on Postoperative Air Leak [NCT02502643]80 participants (Anticipated)Interventional2015-07-31Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT03427619 (4) [back to overview]Change From Baseline in Lesion Volume
NCT03427619 (4) [back to overview]Number of Participants With Clinical Success at 1 to 6 Months Post-Therapy as Assessed by Imaging
NCT03427619 (4) [back to overview]Number of Participants With Investigator-Evaluated Overall Response
NCT03427619 (4) [back to overview]Number of Participants With Clinical Response 1 to 6 Months Post-Therapy as Assessed by Imaging

Change From Baseline in Lesion Volume

Percent change from baseline in lesion volume - pre-therapy to post therapy assessed by imaging. (NCT03427619)
Timeframe: Baseline and 1 to 6 Months Post-Therapy

Interventionpercent change (Mean)
OK-432-44.92

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Number of Participants With Clinical Success at 1 to 6 Months Post-Therapy as Assessed by Imaging

Clinical success was defined as having either a complete (90% 100%) or substantial (60% 89%) reduction in lymphatic malformation (LM) volume after treatment. Response was determined using post treatment imaging studies at approximately 1 to 6 months after completion of treatment (NCT03427619)
Timeframe: 1 to 6 Months Post-Therapy

InterventionParticipants (Count of Participants)
OK-43257

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Number of Participants With Investigator-Evaluated Overall Response

"Investigator evaluated post-therapy clinical response based on physical exam and/or ultrasound was categorized as Clinical Improvement or No Change in the size of the cyst." (NCT03427619)
Timeframe: 1 to 6 Months Post-Therapy

InterventionParticipants (Count of Participants)
OK-43280

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Number of Participants With Clinical Response 1 to 6 Months Post-Therapy as Assessed by Imaging

Number of participants who demonstrated a complete (90%-100% reduction in LM volume), substantial (60%-89% reduction in LM volume), intermediate (20%-59% reduction in LM volume), or no (< 20% reduction in LM volume) response 1 to 6 months post-therapy as assessed by imaging (NCT03427619)
Timeframe: 1 to 6 Months Post-Therapy

InterventionParticipants (Count of Participants)
Number of subjects who achieved a complete responseNumber of subjects who achieved a substantial responseNumber of subjects who achieved an intermediate responseNumber of subjects who achieved no response
OK-4324314516

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