NCT02480166

Brief Summary

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

  1. 1.8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6
  2. 2.12-week treatment of SOF/LED for all other HCV-6 populations

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

4 active sites

Status
completed

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

Study Start

First participant enrolled

June 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

September 19, 2017

Completed
Last Updated

September 19, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

June 17, 2015

Results QC Date

July 17, 2017

Last Update Submit

August 21, 2017

Conditions

PT-NANBH

Keywords

hepatitis C, genotype 6

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment

    12 weeks after end of therapy

Secondary Outcomes (1)

  • Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.

    Day 1 of treatment to 12 weeks post treatment

Study Arms (2)

8 weeks SOF/LED

EXPERIMENTAL

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

12 weeks SOF/LED

EXPERIMENTAL

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

Interventions

8 weeks SOF/LEDDRUG

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.

Also known as: Harvoni, Solvaldi
8 weeks SOF/LED
12 weeks SOF/LEDDRUG

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.

Also known as: Harvoni, Solvaldi
12 weeks SOF/LED

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous recipient of a liver transplant
  • Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

San Jose Gastroenterology

San Jose, California, 95128, United States

Location

Liver and Digestive Consultants

Houston, Texas, 77072, United States

Location

Digestive Health Associates

Plano, Texas, 75093, United States

Location

Related Publications (5)

  • Lawitz E, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 Aug 15;369(7):678-9. doi: 10.1056/NEJMc1307641. No abstract available.

    PMID: 23944316BACKGROUND

  • Lam KD, Trinh HN, Do ST, Nguyen TT, Garcia RT, Nguyen T, Phan QQ, Nguyen HA, Nguyen KK, Nguyen LH, Nguyen MH. Randomized controlled trial of pegylated interferon-alfa 2a and ribavirin in treatment-naive chronic hepatitis C genotype 6. Hepatology. 2010 Nov;52(5):1573-80. doi: 10.1002/hep.23889.

    PMID: 21038410BACKGROUND

  • Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93. doi: 10.1056/NEJMoa1316366. Epub 2014 Apr 11.

    PMID: 24725238BACKGROUND

  • Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11.

    PMID: 24725239BACKGROUND

  • Chao DT, Abe K, Nguyen MH. Systematic review: epidemiology of hepatitis C genotype 6 and its management. Aliment Pharmacol Ther. 2011 Aug;34(3):286-96. doi: 10.1111/j.1365-2036.2011.04714.x. Epub 2011 May 29.

    PMID: 21623850BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Limitations and Caveats

Our population was small and our study was not powered to be able to determine significant differences between groups.

Results Point of Contact

Title
Mindie H. Nguyen, MD, MAS
Organization
Stanford University Medical Center
mindiehn@stanford.edu
650-4985691

Study Officials

  • Mindie H Nguyen, MD, MAS

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 24, 2015

Study Start

June 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 19, 2017

Results First Posted

September 19, 2017

Record last verified: 2017-08

Locations

US(4)