Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02996682
Recruitment Status : Completed
First Posted : December 19, 2016
Results First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: SOF/VEL Drug: RBV Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis
Actual Study Start Date : December 26, 2016
Actual Primary Completion Date : February 13, 2018
Actual Study Completion Date : May 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SOF/VEL
SOF/VEL for 12 weeks
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily
Other Name: Epclusa®

Experimental: SOF/VEL + RBV
SOF/VEL + RBV for 12 weeks
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily
Other Name: Epclusa®

Drug: RBV
Capsules administered orally in a divided daily dose
Other Name: Rebetol®




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.

  2. Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) [ Time Frame: Posttreatment Week 24 ]
    SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.

  3. Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment [ Time Frame: Up to 12 weeks ]
  4. Change From Baseline in HCV RNA [ Time Frame: Baseline and up to 12 weeks ]
  5. Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score [ Time Frame: Baseline to Posttreatment Week 24 ]
    MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2.

  6. Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class [ Time Frame: Baseline to Posttreatment Week 24 ]
    CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. CPT scores were calculated using prothrombin activation percentage for the coagulation parameter per Japan's standard.

  7. Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]

    Virologic failure was defined as:

    Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement).




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Chronic HCV-infected males and non-pregnant/non-lactating females
  • Treatment naive or treatment experienced individuals
  • Child-Pugh-Turcotte Score 7-12 at screening

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996682


Locations
Layout table for location information
Japan
Shimonoseki, Yamaguchi, Japan
Bunkyo, Japan
Chiba, Japan
Chuo, Japan
Ehime, Japan
Fukui, Japan
Fukuyama-shi, Japan
Hiroshima, Japan
Ibaraki, Japan
Ichikawa, Japan
Iizuka City, Japan
Iruma, Japan
Izunokuni, Japan
Kashibara, Japan
Kofu, Japan
Kumamoto-shi, Japan
Kurume, Japan
Kyoto, Japan
Miyazaki-shi, Japan
Morioka, Japan
Musashino, Japan
Nagoya, Japan
Nishinomiya, Japan
Okayama, Japan
Omura, Japan
Osaka, Japan
Sapporo, Japan
Sendai, Japan
Shimotsuga-gun, Japan
Suita, Japan
Takamatsu, Japan
Ube, Japan
Yamagata, Japan
Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol  [PDF] November 17, 2016
Statistical Analysis Plan  [PDF] February 27, 2018


Publications of Results:
Takehara T, Kurosaki M, Tanaka Y, Tatsumi T, Ikeda F, Takikawa Y, et al. Sofosbuvir/Velpatasvir with or without Ribavirin for 12 Weeks in HCV-Infected Japanese Subjects with Decompensated Cirrhosis [Presentation]. 54th Annual Meeting of Japan Society of Hepatology; 2018 June 15; Osaka, Japan.

Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02996682     History of Changes
Other Study ID Numbers: GS-US-342-4019
First Posted: December 19, 2016    Key Record Dates
Results First Posted: February 26, 2019
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gilead.com/about/ethics-and-code-of-conduct/policies

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Gilead Sciences:
Communicable Diseases
Hepatitis
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Velpatasvir
RNA Virus Infections
Ribavirin
Sofosbuvir
Antiviral Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Decompensated Cirrhosis

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Hepatitis C
Hepatitis
Liver Cirrhosis
Fibrosis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Ribavirin
Sofosbuvir
Velpatasvir
Sofosbuvir-velpatasvir drug combination
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents