A Multicenter, Open-Label, Extension Clinical Trial to Evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis (PBC)
Status: Recruiting
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Must provide written informed consent and agree to comply with the trial protocol
• Participated and completed SARO.21.001, the double-blind treatment phase study
Locations
United States
Alabama
Zydus US007
NOT_YET_RECRUITING
Birmingham
California
Zydus US013
RECRUITING
Los Angeles
Zydus US011
RECRUITING
Pasadena
Zydus US043
RECRUITING
Sacramento
Colorado
Zydus US022
RECRUITING
Aurora
Connecticut
Zydus US037
RECRUITING
New Haven
Florida
Zydus US027
RECRUITING
Jacksonville
Zydus US006
COMPLETED
Lakewood Rch
Zydus US005
RECRUITING
Miami
Georgia
Zydus US020
RECRUITING
Marietta
Indiana
Zydus US001
RECRUITING
Indianapolis
North Carolina
Zydus US002
RECRUITING
Charlotte
New York
Zydus US035
RECRUITING
Rochester
Pennsylvania
Zydus US015
RECRUITING
Philadelphia
Texas
Zydus US004
NOT_YET_RECRUITING
Houston
Zydus US042
RECRUITING
Houston
Utah
Zydus US031
RECRUITING
Murray
Virginia
Zydus US016
NOT_YET_RECRUITING
Charlottesville
Zydus US039
RECRUITING
Richmond
Washington
Zydus US033
RECRUITING
Seattle
Other Locations
Argentina
Zydus AR001
NOT_YET_RECRUITING
Ciudad Autónoma De Buenos Aires
Zydus AR003
RECRUITING
Ciudad Autónoma De Buenos Aires
Zydus AR005
RECRUITING
Ciudad Autónoma De Buenos Aires
Zydus AR006
RECRUITING
Ciudad Autónoma De Buenos Aires
Zydus AR007
RECRUITING
Ciudad Autónoma De Buenos Aires
Zydus AR004
RECRUITING
Pilar
Turkey
Zydus TR014
NOT_YET_RECRUITING
Adana
Zydus TR016
NOT_YET_RECRUITING
Altındağ
Zydus TR004
NOT_YET_RECRUITING
Ankara
Zydus TR005
NOT_YET_RECRUITING
Bursa
Zydus TR017
NOT_YET_RECRUITING
Cebeli
Zydus TR008
NOT_YET_RECRUITING
Gaziantep
Zydus TR001
NOT_YET_RECRUITING
Istanbul
Zydus TR003
NOT_YET_RECRUITING
Istanbul
Zydus TR009
NOT_YET_RECRUITING
Istanbul
Zydus TR010
NOT_YET_RECRUITING
Istanbul
Zydus TR002
NOT_YET_RECRUITING
Izmir
Zydus TR013
NOT_YET_RECRUITING
Izmir
Zydus TR011
NOT_YET_RECRUITING
Kocaeli
Zydus TR015
NOT_YET_RECRUITING
Melikgazi
Zydus TR006
NOT_YET_RECRUITING
Mersin
Contact Information
Primary
Farheen Shaikh
fshaikh@zydustherapeutics.com
609-730-1900
Backup
Deven Parmar
dparmar@zydustherapeutics.com
609-559-0765
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2027-07-18
Participants
Target number of participants: 150
Treatments
Experimental: Saroglitazar Magnesium 1 mg
Saroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 months).
Related Therapeutic Areas
Sponsors
Leads: Zydus Therapeutics Inc.