Back to resultsEfficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
Primary Purpose
Hepatitis C Virus Infection
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
SOF/VEL
RBV
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring 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
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SOF/VEL
SOF/VEL + RBV
Arm Description
SOF/VEL for 12 weeks
SOF/VEL + RBV for 12 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event
Secondary Outcome Measures
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment
Change From Baseline in HCV RNA
Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
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.
Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class
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.
Percentage of Participants With Virologic Failure
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02996682
Brief Title
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 26, 2016 (Actual)
Primary Completion Date
February 13, 2018 (Actual)
Study Completion Date
May 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SOF/VEL
Arm Type
Experimental
Arm Description
SOF/VEL for 12 weeks
Arm Title
SOF/VEL + RBV
Arm Type
Experimental
Arm Description
SOF/VEL + RBV for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SOF/VEL
Other Intervention Name(s)
Epclusa®
Intervention Description
400/100 mg FDC tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Other Intervention Name(s)
Rebetol®
Intervention Description
Capsules administered orally in a divided daily dose
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Description
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Time Frame
Posttreatment Week 4
Title
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Description
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Time Frame
Posttreatment Week 24
Title
Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment
Time Frame
Up to 12 weeks
Title
Change From Baseline in HCV RNA
Time Frame
Baseline and up to 12 weeks
Title
Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
Description
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.
Time Frame
Baseline to Posttreatment Week 24
Title
Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class
Description
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.
Time Frame
Baseline to Posttreatment Week 24
Title
Percentage of Participants With Virologic Failure
Description
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).
Time Frame
Up to Posttreatment Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Shimonoseki
State/Province
Yamaguchi
Country
Japan
City
Bunkyo
Country
Japan
City
Chiba
Country
Japan
City
Chuo
Country
Japan
City
Ehime
Country
Japan
City
Fukui
Country
Japan
City
Fukuyama-shi
Country
Japan
City
Hiroshima
Country
Japan
City
Ibaraki
Country
Japan
City
Ichikawa
Country
Japan
City
Iizuka City
Country
Japan
City
Iruma
Country
Japan
City
Izunokuni
Country
Japan
City
Kashibara
Country
Japan
City
Kofu
Country
Japan
City
Kumamoto-shi
Country
Japan
City
Kurume
Country
Japan
City
Kyoto
Country
Japan
City
Miyazaki-shi
Country
Japan
City
Morioka
Country
Japan
City
Musashino
Country
Japan
City
Nagoya
Country
Japan
City
Nishinomiya
Country
Japan
City
Okayama
Country
Japan
City
Omura
Country
Japan
City
Osaka
Country
Japan
City
Sapporo
Country
Japan
City
Sendai
Country
Japan
City
Shimotsuga-gun
Country
Japan
City
Suita
Country
Japan
City
Takamatsu
Country
Japan
City
Ube
Country
Japan
City
Yamagata
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
https://www.gilead.com/about/ethics-and-code-of-conduct/policies
Citations:
Citation
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.
Results Reference
result
Learn more about this trial
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
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