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Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480166
First Posted: June 24, 2015
Last Update Posted: September 19, 2017
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.
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Mindie H. Nguyen, Stanford University
  Purpose

The primary objectives of this study are to describe the efficacy of:

  1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6
  2. 12-week treatment of SOF/LED for all other HCV-6 populations

Condition Intervention Phase
PT-NANBH Drug: 8 weeks SOF/LED Drug: 12 weeks SOF/LED Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of Fixed-dose Combination of Sofosbuvir and Ledipasvir for 8 or 12 Weeks for Chronic Hepatitis C Genotype 6

Resource links provided by NLM:


Further study details as provided by Mindie H. Nguyen, Stanford University:

Primary Outcome Measures:
  • Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment [ Time Frame: 12 weeks after end of therapy ]

Secondary Outcome Measures:
  • Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment. [ Time Frame: Day 1 of treatment to 12 weeks post treatment ]
    Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)


Enrollment: 60
Study Start Date: June 2015
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 8 weeks SOF/LED
Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
Drug: 8 weeks SOF/LED
Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
Other Names:
  • Harvoni
  • Solvaldi
Experimental: 12 weeks SOF/LED
Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
Drug: 12 weeks SOF/LED
Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
Other Names:
  • Harvoni
  • Solvaldi

Detailed Description:
The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Male or female, age ≥18 years
  2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6
  3. Selected to start on treatment by their treating providers
  4. Willing and able to provide informed consent
  5. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments
  6. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline
  7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  8. Lactating females must agree to discontinue nursing before the study drug is administered

Exclusion Criteria:

  1. Previous recipient of a liver transplant
  2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)
  Contacts and Locations
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): NCT02480166


Locations
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
San Jose Gastroenterology
San Jose, California, United States, 95128
United States, Texas
Liver and Digestive Consultants
Houston, Texas, United States, 77072
Digestive Health Associates
Plano, Texas, United States, 75093
Sponsors and Collaborators
Stanford University
Gilead Sciences
Investigators
Principal Investigator: Mindie H Nguyen, MD, MAS Stanford University
  More Information

Publications:

Responsible Party: Mindie H. Nguyen, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02480166     History of Changes
Other Study ID Numbers: 33196
First Submitted: June 17, 2015
First Posted: June 24, 2015
Results First Submitted: July 17, 2017
Results First Posted: September 19, 2017
Last Update Posted: September 19, 2017
Last Verified: August 2017

Keywords provided by Mindie H. Nguyen, Stanford University:
hepatitis C, genotype 6

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents