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Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection (ASTRAL-2)

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SOF/VEL
SOF
RBV
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring Hepatitis C, HCV, cirrhosis, Sofosbuvir, Sovaldi, SOF/VEL, GS-5816, GS-7977, liver, Treatment naive, Treatment Experience, genotype 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • HCV RNA ≥ 10^4 IU/mL
  • HCV genotype 2
  • Chronic HCV infection (≥ 6 months)
  • Females of childbearing potential must have a negative serum pregnancy test
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  • Must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator.

Exclusion Criteria:

  • Current or prior history of clinically-significant illness (other than HCV that may interfere with treatment, assessment or compliance with the protocol;
  • Screening electrocardiogram (ECG) with clinically significant abnormalities
  • Laboratory results outside of acceptable ranges at Screening
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Sites / Locations

  • Emory university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SOF/VEL

SOF+RBV

Arm Description

SOF/VEL FDC for 12 weeks

SOF+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 Permanently Discontinued Any Study Drug Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Percentage of Participants With Virologic Failure
Virologic failure was defined as On-treatment virologic failure: 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) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

Full Information

First Posted
August 18, 2014
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02220998
Brief Title
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection
Acronym
ASTRAL-2
Official Title
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection
Keywords
Hepatitis C, HCV, cirrhosis, Sofosbuvir, Sovaldi, SOF/VEL, GS-5816, GS-7977, liver, Treatment naive, Treatment Experience, genotype 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
269 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF/VEL
Arm Type
Experimental
Arm Description
SOF/VEL FDC for 12 weeks
Arm Title
SOF+RBV
Arm Type
Experimental
Arm Description
SOF+RBV for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SOF/VEL
Other Intervention Name(s)
Epclusa®, GS-7977/GS-5816
Intervention Description
SOF/VEL (400/100 mg) FDC tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
SOF
Other Intervention Name(s)
Sovaldi®, GS-7977, PSI-7977
Intervention Description
SOF 400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
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 Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Time Frame
Weeks 1, 2, 4, 6, 8, 10, and 12
Title
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Time Frame
Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12
Title
Percentage of Participants With Virologic Failure
Description
Virologic failure was defined as On-treatment virologic failure: 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) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Time Frame
Up to Posttreatment Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to provide written informed consent HCV RNA ≥ 10^4 IU/mL HCV genotype 2 Chronic HCV infection (≥ 6 months) Females of childbearing potential must have a negative serum pregnancy test Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception Must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator. Exclusion Criteria: Current or prior history of clinically-significant illness (other than HCV that may interfere with treatment, assessment or compliance with the protocol; Screening electrocardiogram (ECG) with clinically significant abnormalities Laboratory results outside of acceptable ranges at Screening Pregnant or nursing female or male with pregnant female partner Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anu Osinusi, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0272
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Emory university
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71280
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico

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 http://www.gilead.com/research/disclosure-and-transparency.
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
http://www.gilead.com/research/disclosure-and-transparency
Citations:
Citation
Asselah T, Charlton M, Feld J, Foster GR, Mcnally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015;62:S855-S6.
Results Reference
result
Citation
Sulkowski, MS., Brau N., Lawitz E., Shiffman ML, Towner WL, Ruane PJ et al. A Randomized Controlled Trial of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks Compared to Sofosbuvir with Ribavirin for 12 Weeks in Genotype 2 HCV Infected Patients: The Phase 3 ASTRAL-2 Study [Oral 205] Hepatology 2015; 62: 1 (SUPPL) 313A.
Results Reference
result
PubMed Identifier
26575258
Citation
Foster GR, Afdhal N, Roberts SK, Brau N, Gane EJ, Pianko S, Lawitz E, Thompson A, Shiffman ML, Cooper C, Towner WJ, Conway B, Ruane P, Bourliere M, Asselah T, Berg T, Zeuzem S, Rosenberg W, Agarwal K, Stedman CA, Mo H, Dvory-Sobol H, Han L, Wang J, McNally J, Osinusi A, Brainard DM, McHutchison JG, Mazzotta F, Tran TT, Gordon SC, Patel K, Reau N, Mangia A, Sulkowski M; ASTRAL-2 Investigators; ASTRAL-3 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med. 2015 Dec 31;373(27):2608-17. doi: 10.1056/NEJMoa1512612. Epub 2015 Nov 17.
Results Reference
result
PubMed Identifier
27847279
Citation
Younossi ZM, Stepanova M, Feld J, Zeuzem S, Sulkowski M, Foster GR, Mangia A, Charlton M, O'Leary JG, Curry MP, Nader F, Henry L, Hunt S. Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2017 Mar;15(3):421-430.e6. doi: 10.1016/j.cgh.2016.10.037. Epub 2016 Nov 12.
Results Reference
derived

Learn more about this trial

Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection

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