Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
![]() |
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: NCT01726517 |
Recruitment Status :
Completed
First Posted : November 15, 2012
Results First Posted : November 17, 2014
Last Update Posted : November 16, 2018
|
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | November 10, 2012 | ||||||||||||||
First Posted Date ICMJE | November 15, 2012 | ||||||||||||||
Results First Submitted Date ICMJE | November 7, 2014 | ||||||||||||||
Results First Posted Date ICMJE | November 17, 2014 | ||||||||||||||
Last Update Posted Date | November 16, 2018 | ||||||||||||||
Study Start Date ICMJE | October 2012 | ||||||||||||||
Actual Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||||||||
Original Primary Outcome Measures ICMJE |
|
||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||||||||
Original Secondary Outcome Measures ICMJE |
|
||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects | ||||||||||||||
Official Title ICMJE | A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection | ||||||||||||||
Brief Summary | This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV. | ||||||||||||||
Detailed Description | Not Provided | ||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||||||||
Condition ICMJE | Chronic Hepatitis C Virus | ||||||||||||||
Intervention ICMJE |
|
||||||||||||||
Study Arms ICMJE |
|
||||||||||||||
Publications * | Lawitz E, Poordad FF, Pang PS, Hyland RH, Ding X, Mo H, Symonds WT, McHutchison JG, Membreno FE. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014 Feb 8;383(9916):515-23. doi: 10.1016/S0140-6736(13)62121-2. Epub 2013 Nov 5. Erratum In: Lancet. 2014 Mar 8;383(9920):870. | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||
Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||
Actual Enrollment ICMJE |
100 | ||||||||||||||
Original Estimated Enrollment ICMJE |
60 | ||||||||||||||
Actual Study Completion Date ICMJE | January 2014 | ||||||||||||||
Actual Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||
Sex/Gender ICMJE |
|
||||||||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT01726517 | ||||||||||||||
Other Study ID Numbers ICMJE | GS-US-337-0118 | ||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||
IPD Sharing Statement ICMJE |
|
||||||||||||||
Current Responsible Party | Gilead Sciences | ||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||
Current Study Sponsor ICMJE | Gilead Sciences | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
|
||||||||||||||
PRS Account | Gilead Sciences | ||||||||||||||
Verification Date | November 2014 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |