NCT01910636

Brief Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

19 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

February 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 24, 2015

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

July 23, 2013

Results QC Date

March 13, 2015

Last Update Submit

March 13, 2015

Conditions

Hepatitis C

Keywords

HCV genotype 2 (GT-2)

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

    Posttreatment Week 12

  • Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

    The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.

    Up to 12 weeks

Secondary Outcomes (3)

  • Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    Posttreatment Weeks 4 and 24

  • Percentage of Participants Experiencing Viral Breakthrough

    Up to 12 weeks

  • Percentage of Participants Experiencing Viral Relapse

    Up to Posttreatment Week 24

Study Arms (1)

Sofosbuvir+RBV 12 weeks

EXPERIMENTAL

Participants will receive sofosbuvir+RBV for 12 weeks.

Drug: SofosbuvirDrug: RBV

Interventions

SofosbuvirDRUG

Sofosbuvir 400 mg tablet administered orally once daily

Also known as: GS-7977, PSI-7977, Sovaldi®
Sofosbuvir+RBV 12 weeks
RBVDRUG

Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Also known as: Copegus®
Sofosbuvir+RBV 12 weeks

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic genotype 2 HCV-infection
  • Male or female, age ≥ 20 years
  • Body weight ≥ 40 kg
  • HCV RNA ≥ 10,000 IU/mL at screening

You may not qualify if:

  • Current or prior history of clinically significant illness other than HCV
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Akita, Japan

Location

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Chiyoda-ku, Japan

Location

Unknown Facility

Gifu, Japan

Location

Unknown Facility

Ichikawa, Japan

Location

Unknown Facility

Itabashi-ku, Japan

Location

Unknown Facility

Izunokuni, Japan

Location

Unknown Facility

Kita-ku, Japan

Location

Unknown Facility

Kurashiki, Japan

Location

Unknown Facility

Kurume, Japan

Location

Unknown Facility

Matsumoto, Japan

Location

Unknown Facility

Musashino, Japan

Location

Unknown Facility

Nishinomiya, Japan

Location

Unknown Facility

Ōgaki, Japan

Location

Unknown Facility

Ōmura, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Shinjuku-ku, Japan

Location

Unknown Facility

Suita, Japan

Location

Unknown Facility

Yamagata, Japan

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

SofosbuvirRibavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesRibonucleosidesNucleosides

Results Point of Contact

Title
Clinical Trial Disclosures
Organization
Gilead Sciences
ClinicalTrialDisclosures@gilead.com

Study Officials

  • Steven Knox

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 29, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

March 24, 2015

Results First Posted

March 24, 2015

Record last verified: 2015-03

Locations

JP(19)