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Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

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: NCT01987453
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : January 10, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).

Condition or disease Intervention/treatment Phase
HCV Infection Drug: LDV/SOF Drug: RBV Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin For 12 or 24 Weeks In Chronic Genotype 1 HCV Infected Subjects Who Participated In A Prior Gilead-Sponsored HCV Treatment Study
Study Start Date : July 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LDV/SOF+RBV 12 weeks (Group 1)
Participants who failed a prior SOF+RBV ± pegylated interferon (Peg-IFN) regimen will receive LDV/SOF FDC plus RBV for 12 weeks.
Drug: LDV/SOF
Tablet(s) administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

Drug: 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)

Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert.


Experimental: LDV/SOF 24 weeks (Group 2)
Participants who failed a prior LDV/SOF ± RBV regimen will receive LDV/SOF FDC for 24 weeks.
Drug: LDV/SOF
Tablet(s) administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

Experimental: LDV/SOF+RBV 24 weeks (Group 3)
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen will receive LDV/SOF FDC plus RBV for 24 weeks.
Drug: LDV/SOF
Tablet(s) administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

Drug: 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)

Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert.





Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Post-treatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 24 Weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]
    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.

  2. Percentage of Participants With HCV RNA < LLOQ While on Treatment [ Time Frame: Baseline to Week 24 ]
  3. Change in HCV RNA From Baseline [ Time Frame: Baseline to Week 8 ]
  4. Percentage of Participants With Virologic Failure [ Time Frame: Up to posttreatment Week 24 ]

    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 confirmed with 2 consecutive values or last available posttreatment 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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Infection with HCV genotype 1
  • HCV RNA > LLOQ at screening
  • Participation in a prior Gilead-sponsored study
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male
  • Must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
  • Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Key Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner
  • Co-infection with HIV or hepatitis B virus (HBV)
  • Current or prior history of clinical hepatic decompensation (Groups 1 and 2 only)
  • Hepatocellular carcinoma (HCC)
  • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

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): NCT01987453


Locations
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United States, California
Beverly Hills, California, United States, 90210
La Jolla, California, United States, 92037
Los Angeles, California, United States, 90027
Los Angeles, California, United States, 90036
Los Angeles, California, United States, 90069
Oceanside, California, United States, 92056
San Diego, California, United States, 92103
San Francisco, California, United States, 94115
United States, Colorado
Aurora, Colorado, United States, 80045
United States, District of Columbia
Washington, District of Columbia, United States, 20009
United States, Florida
Gainesville, Florida, United States, 32610
Jacksonville, Florida, United States, 32256
Miami, Florida, United States, 33136
Orlando, Florida, United States, 32803
Wellington, Florida, United States, 33414
United States, Georgia
Marietta, Georgia, United States, 30060
United States, Illinois
Chicago, Illinois, United States, 60611
Downers Grove, Illinois, United States, 60515
United States, Indiana
Indianapolis, Indiana, United States, 46237
United States, Kentucky
Bowling Green, Kentucky, United States, 42101
United States, Louisiana
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Boston, Massachusetts, United States, 02215
Springfield, Massachusetts, United States, 01105
United States, Minnesota
Minneapolis, Minnesota, United States, 55414
United States, Missouri
Kansas City, Missouri, United States, 64131
United States, New Jersey
Hillsborough, New Jersey, United States, 08844
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Binghamton, New York, United States, 13903
Manhasset, New York, United States, 11030
New York, New York, United States, 10029
United States, North Carolina
Asheville, North Carolina, United States, 28801
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Germantown, Tennessee, United States, 38138
United States, Texas
San Antonio, Texas, United States, 78215
United States, Virginia
Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23226
United States, Washington
Seattle, Washington, United States, 98111
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
France
Clichy, France, 92110
Puerto Rico
San Juan, Puerto Rico, 00927
Spain
Barcelona, Spain, 08028
Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences

Publications of Results:
Other Publications:
Lawitz E, Pockros PJ, Yang JC, Pang PS, Zhu Y, Svarovskaia E, et al. Ledipasvir/sofosbuvir regimens for the retreatment of patients who failed sofosbuvir-based regimens [Abstract 10868]. Presented at: The 25th Conference of the Asian Pacific Association for the Study of Liver (APASL); 2016 February 20-24; Tokyo, Japan.
Lawitz E, Flamm S, Yang JC, Pang PS, Zhu Y, Svarovskaia E, et al. Retreatment of patients who failed 8 or 12 weeks of ledipasvir/sofosbuvir-based regimens with ledipasvir/sofosbuvir for 24 weeks [Abstract 1627]. Presented at: The 50th Annual Congress of the European Association for the Study of Liver: The International Liver Congress (EASL); 2015 April 22-26; Vienna, Austria

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01987453    
Other Study ID Numbers: GS-US-337-1118
2014-001245-24 ( EudraCT Number )
First Posted: November 19, 2013    Key Record Dates
Results First Posted: January 10, 2017
Last Update Posted: November 19, 2018
Last Verified: November 2016
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 http://www.gilead.com/research/disclosure-and-transparency.
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: http://www.gilead.com/research/disclosure-and-transparency
Keywords provided by Gilead Sciences:
genotype 1
Additional relevant MeSH terms:
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Sofosbuvir
Ledipasvir
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents