Study Stopped
Due to lack of feasibility of enrolling participants, the study was terminated early.
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Subjects Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
1 other identifier
interventional
87
3 countries
42
Brief Summary
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2015
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 9, 2015
CompletedStudy Start
First participant enrolled
November 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2017
CompletedResults Posted
Study results publicly available
April 11, 2018
CompletedNovember 16, 2018
August 1, 2018
1.4 years
November 5, 2015
March 13, 2018
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Cessation 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.
Posttreatment Week 12
Percentage of Participants Who Discontinued From Study Treatment for an Adverse Event
Up to 24 weeks
Secondary Outcomes (4)
Percentage of Participants With HCV RNA < the Lower Limit of Quantitation (LLOQ) at 4 and 24 Weeks Posttreatment
Posttreatment Weeks 4 and 24
Percentage of Participants With Viral Breakthrough
Up to 24 weeks
Percentage of Participants With Viral Relapse
Up to Posttreatment Week 24
Number of Participants With Emerging Resistance
Up to Posttreatment Week 24
Study Arms (4)
LDV/SOF 12 weeks, without cirrhosis
EXPERIMENTALLDV/SOF for 12 weeks
LDV/SOF + RBV 12 weeks, without cirrhosis
EXPERIMENTALLDV/SOF + RBV for 12 weeks
LDV/SOF + RBV 12 weeks, with compensated cirrhosis
EXPERIMENTALLDV/SOF + RBV for 12 weeks
LDV/SOF 24 weeks, with compensated cirrhosis
EXPERIMENTALLDV/SOF for 24 weeks
Interventions
90/400 mg FDC tablet administered orally once daily
Tablets administered orally in a divided daily dose according to weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Eligibility Criteria
You may qualify if:
- HCV RNA \> 15 IU/mL at screening
- HCV genotype 1 or 4
- Chronic HCV infection (≥ 6 months)
- Prior virologic failure after treatment with SOF in combination with simeprevir (SMV) ± RBV or with RBV ± pegylated interferon (PEG)
- Cirrhotic and non-cirrhotic as determined by standard methods
- Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
You may not qualify if:
- Prior exposure to approved or experimental non-structural protein (NS5A) inhibitors
- Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF
- Pregnant or nursing female or male with pregnant female partner
- Coinfection with HIV or hepatitis B virus
- Current or prior history of clinical hepatic decompensation
- Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (42)
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Los Angeles, California, 90027, United States
Unknown Facility
Pasadena, California, 91105, United States
Unknown Facility
Rialto, California, 92377, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
Ventura, California, 93003, United States
Unknown Facility
New Haven, Connecticut, 06520, United States
Unknown Facility
Largo, Florida, 33777, United States
Unknown Facility
Weston, Florida, 33331, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Skokie, Illinois, 60076, United States
Unknown Facility
Baltimore, Maryland, 21202, United States
Unknown Facility
Columbia, Maryland, 21045, United States
Unknown Facility
Worcester, Massachusetts, 01655, United States
Unknown Facility
Saint Paul, Minnesota, 55114, United States
Unknown Facility
Kansas City, Missouri, 64131, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Egg Harbor, New Jersey, 08234, United States
Unknown Facility
New York, New York, 10025, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
The Bronx, New York, 10467, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Charlotte, North Carolina, 28204, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cleveland, Ohio, 44109, United States
Unknown Facility
Columbus, Ohio, 43212, United States
Unknown Facility
Philadelphia, Pennsylvania, 19141, United States
Unknown Facility
Memphis, Tennessee, 38104, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Austin, Texas, 78758, United States
Unknown Facility
Dallas, Texas, 75203, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Dallas, Texas, 75390, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Charlottesville, Virginia, 22908, United States
Unknown Facility
Seattle, Washington, 98101, United States
Unknown Facility
Seattle, Washington, 98122, United States
Unknown Facility
Vancouver, British Columbia, V5Z 1H2, Canada
Unknown Facility
Montreal, Quebec, H2L 4P9, Canada
Unknown Facility
Montreal, Quebec, H4A 3J1, Canada
Unknown Facility
Ponce, PR, 00716, Puerto Rico
Related Publications (4)
Tam E, Brown RS, Satapathy S, Shen X, Camus G, Copans A, et al. Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF), with or without Ribavirin (RBV), for Treatment of HCV-mono and HIV/HCV Co-infected Patients Who Have Failed Prior Treatment with Non-NS5A, SOF-based Therapies [Poster THU-265]. The International Liver Congressâ„¢ 2017: European Association for the Study of the Liver (EASL); 2017 19-23 April; Amsterdam, the Netherlands.
RESULTTam E, Mantry PS, Satapathy SK, Ghali P, Shen X, Han LL, et al. A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF), with or without Ribavirin (RBV), in HCV Infected Subjects Who Have Failed Prior Treatment with Non-NS5A, SOF-based Therapies (RESCUE) [Poster PP0217]. Asian Pacific Association for the Study of the Liver (APASL); 2017 15-19 February; Shanghai, China.
RESULTTam E, Brown RS, Satapathy S, Camus G, Copans A, Rossaro L, et al. Ledipasvir/Sofosbuvir ± Ribavirin in HCV and HIV/HCV Prior SOF-based Virologic Failures (RESCUE and ACTG A5348 Studies) [Poster 568LB]. Conference on Retroviruses and Opportunistic Infections (CROI); 2017 13-16 February; Seattle, WA.
RESULTTam E, Luetkemeyer AF, Mantry PS, Satapathy SK, Ghali P, Kang M, Haubrich R, Shen X, Ni L, Camus G, Copans A, Rossaro L, Guyer B, Brown RS Jr; RESCUE and ACTG A5348 study investigators. Ledipasvir/sofosbuvir for treatment of hepatitis C virus in sofosbuvir-experienced, NS5A treatment-naive patients: Findings from two randomized trials. Liver Int. 2018 Jun;38(6):1010-1021. doi: 10.1111/liv.13616. Epub 2017 Dec 5.
PMID: 29091342RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to lack of feasibility of enrolling participants, the study was terminated early. Although, the non-inferiority tests were performed, the actual sample size was inadequate compared to the planned enrollment of 430 participants.
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 9, 2015
Study Start
November 11, 2015
Primary Completion
March 21, 2017
Study Completion
May 29, 2017
Last Updated
November 16, 2018
Results First Posted
April 11, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
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.