NCT01713283

Brief Summary

This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

October 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

November 25, 2014

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

1.1 years

First QC Date

October 17, 2012

Results QC Date

November 18, 2014

Last Update Submit

November 18, 2014

Conditions

Hepatitis C Virus

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 discontinuing any study drug due to an adverse event was summarized.

    Up to 24 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 On-treatment Virologic Failure

    Up to 24 weeks

  • Percentage of Participants Experiencing Viral Relapse

    Up to Posttreatment Week 24

Study Arms (2)

SOF+RBV 12 Weeks

EXPERIMENTAL

Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks.

Drug: SOFDrug: RBV

SOF+RBV 24 Weeks

EXPERIMENTAL

Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks.

Drug: SOFDrug: RBV

Interventions

SOFDRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

Also known as: GS-7977, PSI-7977, Sovaldi®
SOF+RBV 12 WeeksSOF+RBV 24 Weeks
RBVDRUG

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

SOF+RBV 12 WeeksSOF+RBV 24 Weeks

Eligibility Criteria

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

You may qualify if:

  • First generation Egyptian; must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry
  • Treatment-experienced or treatment-naive
  • Chronic genotype 4 HCV infection
  • Not co-infected with HIV
  • Screening laboratory values within defined thresholds
  • Use of highly effective contraception methods
  • Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

You may not qualify if:

  • History of any other clinically significant chronic liver disease
  • Pregnant or nursing female or male with pregnant female partner
  • History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol
  • Excessive alcohol ingestion or significant drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Los Angeles, California, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir

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 NucleosidesRibonucleotides

Results Point of Contact

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

Study Officials

  • Kathryn Kersey, MSc

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 24, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2013

Study Completion

February 1, 2014

Last Updated

November 25, 2014

Results First Posted

November 25, 2014

Record last verified: 2014-11

Locations

US(1)