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Safety, Tolerability, and Efficacy of GS-9674 in Adults With Primary Sclerosing Cholangitis Without Cirrhosis (PSC-Phase 2)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02943460
First received: June 13, 2016
Last updated: June 20, 2017
Last verified: June 2017
  Purpose
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in adults with primary sclerosing cholangitis (PSC).

Condition Intervention Phase
Primary Sclerosing Cholangitis Drug: GS-9674 Drug: Placebo to match GS-9674 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Primary Sclerosing Cholangitis Without Cirrhosis

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to 12 weeks plus 30 days ]
  • Incidence of Treatment-Emergent Serious Adverse Events [ Time Frame: Up to 12 weeks plus 30 days ]
  • Incidence of treatment-emergent laboratory abnormalities [ Time Frame: Up to 12 weeks plus 30 days ]

Estimated Enrollment: 50
Actual Study Start Date: November 29, 2016
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-9674 30 mg (Blinded Study Phase)
GS-9674 30 mg + placebo to match GS-9674 100 mg for 12 weeks
Drug: GS-9674
Tablet(s) administered orally once daily
Drug: Placebo to match GS-9674
Tablet(s) administered orally once daily
Experimental: GS-9674 100 mg (Blinded Study Phase)
GS-9674 100 mg + placebo to match GS-9674 30 mg for 12 weeks
Drug: GS-9674
Tablet(s) administered orally once daily
Drug: Placebo to match GS-9674
Tablet(s) administered orally once daily
Placebo Comparator: Placebo (Blinded Study Phase)
Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 12 weeks
Drug: Placebo to match GS-9674
Tablet(s) administered orally once daily
Experimental: GS-9674 (Open Label Extension Phase)
Following the Blinded Study Phase, eligible participants may have the option to receive GS-9674 for an additional 96 weeks.
Drug: GS-9674
Tablet(s) administered orally once daily

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diagnosis of PSC based on cholangiogram (magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), or percutaneous transhepatic cholangiogram (PTC)) within the previous 12 months
  • Serum alkaline phosphatase (ALP) > 1.67 x upper limit of the normal range (ULN)
  • For individuals on ursodeoxycholic acid (UDCA), the dose of UDCA must have been stable for at least 12 months prior to screening through the end of treatment. For individuals not on UDCA, no UDCA use for at least 12 months before screening through the end of treatment
  • Screening FibroSURE/FibroTest® <0.75 unless a historical liver biopsy within 12 months of screening does not reveal cirrhosis. In adults with Gilbert's syndrome or hemolysis, FibroSURE/FibroTest® will be calculated using direct bilirubin instead of total bilirubin.

Key Exclusion Criteria:

  • Alanine aminotransferase (ALT) > 10 x ULN
  • Total bilirubin > 2 x ULN
  • International normalized ratio (INR) > 1.2 unless on anticoagulant therapy
  • Small-duct PSC (histologic evidence of PSC with normal bile ducts on cholangiography)
  • Other causes of liver disease including secondary sclerosing cholangitis and viral, metabolic, alcoholic, and other autoimmune conditions
  • Ascending cholangitis within 60 days of screening
  • Presence of a percutaneous drain or bile duct stent
  • Use of fibrates or obeticholic acid within 3 months prior to screening through the end of treatment
  • Cirrhosis of the liver as defined by any of the following:

    • Historical liver biopsy demonstrating cirrhosis (eg, Ludwig stage 4 or Ishak stage ≥ 5)
    • Prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
    • Liver stiffness > 14.4 kPa by FibroScan
  • Current, active inflammatory bowel disease (IBD) defined as a partial Mayo score of > 1 and/or a score on the Rectal Bleeding domain > 0.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02943460

Contacts
Contact: Gilead Study Team GS-US-428-4025@Gilead.com

  Show 34 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02943460     History of Changes
Other Study ID Numbers: GS-US-428-4025
2016-002442-23 ( EudraCT Number )
Study First Received: June 13, 2016
Last Updated: June 20, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 22, 2017