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Trial record 36 of 3192 for:    "Hepatitis, Viral, Human"

Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

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ClinicalTrials.gov Identifier: NCT01838590
Recruitment Status : Completed
First Posted : April 24, 2013
Results First Posted : May 22, 2015
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Drug: SOF Drug: RBV Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection.
Study Start Date : March 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SOF+RBV 12 Weeks
Participants will receive SOF+RBV for 12 weeks.
Drug: SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Experimental: SOF+RBV 24 Weeks
Participants will receive SOF+RBV for 24 weeks.
Drug: SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]
    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

  2. Percentage of Participants Experiencing On-treatment Virologic Failure [ Time Frame: Up to 24 weeks ]

    On-treatment virologic failure was defined as

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

  3. Percentage of Participants Experiencing Virologic Relapse [ Time Frame: Up to Posttreatment Week 24 ]
    Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.



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

Inclusion Criteria:

  • Treatment experienced and naïve subjects
  • Chronic genotype 4 HCV-infection
  • Not co-infected with HIV
  • Screening laboratory values within defined thresholds
  • Use of highly effective contraception methods
  • Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.

Exclusion Criteria:

  • 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 subject treatment, assessment or compliance with the protocol
  • Excessive alcohol ingestion or significant drug abuse

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): NCT01838590


Locations
Egypt
Cairo, Egypt
Mansoura, Egypt
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Kathryn Kersey Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01838590     History of Changes
Other Study ID Numbers: GS-US-334-0138
First Posted: April 24, 2013    Key Record Dates
Results First Posted: May 22, 2015
Last Update Posted: May 22, 2015
Last Verified: May 2015

Keywords provided by Gilead Sciences:
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
HCV genotype 4 (GT-4)
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
GS-7977
Ribavirin
Open Label
Sofosbuvir
Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:
Hepatitis, Viral, Human
Infection
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Sofosbuvir
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents