Page last updated: 2024-10-23

berberine and Cholangitis, Sclerosing

berberine has been researched along with Cholangitis, Sclerosing in 2 studies

Cholangitis, Sclerosing: Chronic inflammatory disease of the BILIARY TRACT. It is characterized by fibrosis and hardening of the intrahepatic and extrahepatic biliary ductal systems leading to bile duct strictures, CHOLESTASIS, and eventual BILIARY CIRRHOSIS.

Research Excerpts

Excerpt	Relevance	Reference
"Effective pharmacologic treatment of primary sclerosing cholangitis (PSC) remains elusive."	3.11	Berberine Ursodeoxycholate for the Treatment of Primary Sclerosing Cholangitis: The Search for the Elusive Pharmacologic Holy Grail Will Need to Continue. ( Yoshida, EM, 2022)
"Primary sclerosing cholangitis (PSC) is a fibroinflammatory disease of the bile ducts leading to cirrhosis and hepatic decompensation."	3.11	A Randomized, Dose-Finding, Proof-of-Concept Study of Berberine Ursodeoxycholate in Patients With Primary Sclerosing Cholangitis. ( Di Bisceglie, AM; Eksteen, B; Forman, L; Gunn, N; Harrison, SA; Hirschfield, GM; Kowdley, KV; Landis, C; Levy, C; Liberman, A; Sundaram, V, 2022)

Research

Studies (2)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	0 (0.00)	24.3611
2020's	2 (100.00)	2.80

Authors

Authors	Studies
Yoshida, EM	1
Kowdley, KV	1
Forman, L	1
Eksteen, B	1
Gunn, N	1
Sundaram, V	1
Landis, C	1
Harrison, SA	1
Levy, C	1
Liberman, A	1
Di Bisceglie, AM	1
Hirschfield, GM	1

Clinical Trials (1)

Trial Overview

Trial			Phase	Enrollment	Study Type	Start Date	Status
A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects With Primary Sclerosing Cholangitis (PSC)[NCT03333928]			Phase 2	59 participants (Actual)	Interventional	2018-02-09	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Absolute Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 6 in Period 1

(NCT03333928)
Timeframe: Baseline to Week 6

Intervention	U/L (Least Squares Mean)
HTD1801 500 mg BID	-53
HTD1801 1000 mg BID	-37
Placebo BID	98

Absolute Change in Serum ALP From Week 12 to Week 18 (Period 3)

Change in serum ALP between a new baseline at Week 12 and the final value at Week 18 for all subjects following the randomized withdrawal (NCT03333928)
Timeframe: Week 12 to Week 18

Intervention	U/L (Mean)
HTD1801 500 mg BID to HTD1801 500 mg BID	-63
HTD1801 1000 mg BID to HTD1801 1000 mg BID	21
HTD1801 500 mg BID to Placebo	183
HTD1801 1000 mg BID to Placebo	142

Absolute Change in Serum ALP From Week 6 to Week 12 (Period 2)

(NCT03333928)
Timeframe: Week 6 to Week 12

Intervention	U/L (Mean)
Placebo to HTD1801 500 mg BID	-34
HTD1801 500 mg BID to HTD1801 500 mg BID	-14
Placebo to HTD1801 1000 mg BID	-189
HTD1801 1000 mg BID to HTD1801 1000 mg BID	10

Absolute Change in Serum Total Bilirubin at the End of Week 12 (Period 2)

(NCT03333928)
Timeframe: Week 6 to Week 12

Intervention	mg/dL (Mean)
Placebo to HTD1801 500 mg BID	-0.1
HTD1801 500 mg BID to HTD1801 500 mg BID	0.0
Placebo to HTD1801 1000 mg BID	-0.4
HTD1801 1000 mg BID to HTD1801 1000 mg BID	0.0

Absolute Change in Serum Total Bilirubin at the End of Week 18 (Period 3)

(NCT03333928)
Timeframe: Week 12 to Week 18

Intervention	mg/dL (Mean)
HTD1801 500 mg BID to HTD1801 500 mg BID	-0.2
HTD1801 1000 mg BID to HTD1801 1000 mg BID	0.0
HTD1801 500 mg BID to Placebo	0.1
HTD1801 1000 mg BID to Placebo	0.1

Absolute Change in Serum Total Bilirubin at the End of Week 6 (Period 1)

(NCT03333928)
Timeframe: Baseline to Week 6

Intervention	mg/dL (Mean)
HTD1801 500 mg BID	-0.2
HTD1801 1000 mg BID	0.0
Placebo BID	0.1

Percentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 12 (Period 2)

(NCT03333928)
Timeframe: Week 6 to Week 12

Intervention	Participants (Count of Participants)
Placebo to HTD1801 500 mg BID	1
HTD1801 500 mg BID to HTD1801 500 mg BID	0
Placebo to HTD1801 1000 mg BID	0
HTD1801 1000 mg BID to HTD1801 1000 mg BID	2

Percentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 18 (Period 3)

(NCT03333928)
Timeframe: Week 12 to Week 18

Intervention	Participants (Count of Participants)
HTD1801 500 mg BID to HTD1801 500 mg BID	1
HTD1801 1000 mg BID to HTD1801 1000 mg BID	0
HTD1801 500 mg BID to Placebo	0
HTD1801 1000 mg BID to Placebo	1

Percentage of Patients Who Achieve ALP of <1.5 x ULN at the End of Week 18 (Period 3)

The percentage of patients who achieve ALP of <1.5 x ULN at the end of week 18 (Period 3) (NCT03333928)
Timeframe: Week 12 to Week 18

Intervention	Participants (Count of Participants)
HTD1801 500 mg BID to HTD1801 500 mg BID	1
HTD1801 1000 mg BID to HTD1801 1000 mg BID	4
HTD1801 500 mg BID to Placebo	0
HTD1801 1000 mg BID to Placebo	1

Percentage of Patients Who Normalize ALP at the End of Week 12 (Period 2)

(NCT03333928)
Timeframe: Week 6 to Week 12

Intervention	Participants (Count of Participants)
Placebo to HTD1801 500 mg BID	0
HTD1801 500 mg BID to HTD1801 500 mg BID	0
Placebo to HTD1801 1000 mg BID	0
HTD1801 1000 mg BID to HTD1801 1000 mg BID	2

Percentage of Subjects Who Achieve a 50% Decrease in ALP at the End of Week 6 (Period 1)

(NCT03333928)
Timeframe: Baseline to Week 6

Intervention	Participants (Count of Participants)
HTD1801 500 mg BID	1
HTD1801 1000 mg BID	4
Placebo BID	0

Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 12 (Period 2)

(NCT03333928)
Timeframe: Week 6 to Week 12

Intervention	Participants (Count of Participants)
Placebo to HTD1801 500 mg BID	0
HTD1801 500 mg BID to HTD1801 500 mg BID	2
Placebo to HTD1801 1000 mg BID	0
HTD1801 1000 mg BID to HTD1801 1000 mg BID	6

Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 6 (Period 1)

(NCT03333928)
Timeframe: Baseline to Week 6

Intervention	Participants (Count of Participants)
HTD1801 500 mg BID	2
HTD1801 1000 mg BID	6
Placebo BID	1

Percentage of Subjects Who Normalize ALP at the End of Week 18 (Period 3)

(NCT03333928)
Timeframe: Week 12 to Week 18

Intervention	Participants (Count of Participants)
HTD1801 500 mg BID to HTD1801 500 mg BID	0
HTD1801 1000 mg BID to HTD1801 1000 mg BID	1
HTD1801 500 mg BID to Placebo	0
HTD1801 1000 mg BID to Placebo	0

Percentage of Subjects Who Normalize ALP at the End of Week 6 (Period 1)

(NCT03333928)
Timeframe: Baseline to Week 6

Intervention	Participants (Count of Participants)
HTD1801 500 mg BID	0
HTD1801 1000 mg BID	2
Placebo BID	0

Trials

2 trials available for berberine and Cholangitis, Sclerosing

Article	Year
Berberine Ursodeoxycholate for the Treatment of Primary Sclerosing Cholangitis: The Search for the Elusive Pharmacologic Holy Grail Will Need to Continue. The American journal of gastroenterology, 2022, 11-01, Volume: 117, Issue:11 Topics: Alkaline Phosphatase; Berberine; Bile Acids and Salts; Cholagogues and Choleretics; Cholangitis, Scl	2022
A Randomized, Dose-Finding, Proof-of-Concept Study of Berberine Ursodeoxycholate in Patients With Primary Sclerosing Cholangitis. The American journal of gastroenterology, 2022, 11-01, Volume: 117, Issue:11 Topics: Alkaline Phosphatase; Berberine; Bile Acids and Salts; Cholangitis, Sclerosing; Humans; Treatment Ou	2022