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Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

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ClinicalTrials.gov Identifier: NCT02175758
Recruitment Status : Active, not recruiting
First Posted : June 26, 2014
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

This study will have two parts as follows:

The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.

The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively.


Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: SOF (oral tablets) Drug: RBV Drug: SOF (oral granules) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Actual Study Start Date : July 7, 2014
Actual Primary Completion Date : June 21, 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SOF+RBV 7 days (PK Lead-in, Cohort 1)
Participants between and including the ages of 12 and 17 years old weighing ≥ 45 kg will receive SOF tablets (400 mg: 1 x 400 mg, or 4 x 100 mg) + RBV for 7 days. If participants are unable to swallow SOF tablets, they will receive SOF oral granules (400 mg: 8 x 50mg). Participants will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Drug: SOF (oral tablets)
SOF tablets administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: RBV
RBV administered as capsules or oral solution
Other Name: REBETOL®

Drug: SOF (oral granules)
SOF oral granule capsules administered orally once daily
Other Name: GS-7977

Experimental: SOF+RBV 7 days (PK Lead-in, Cohort 2)
Following completion of study treatment in Cohort 1 and pending PK and safety results, participants between and including the ages of 6 and 11 years old weighing ≥ 17 kg and < 45 kg will receive SOF tablets (200 mg: 2 x 100 mg) + RBV for 7 days. If participants are unable to swallow SOF tablets, they will receive SOF oral granules (200 mg: 4 x 50mg). Participants will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Drug: SOF (oral tablets)
SOF tablets administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: RBV
RBV administered as capsules or oral solution
Other Name: REBETOL®

Drug: SOF (oral granules)
SOF oral granule capsules administered orally once daily
Other Name: GS-7977

Experimental: SOF+RBV 7 days (PK Lead-in, Cohort 3)
Following completion of study treatment in Cohort 2 and pending PK and safety results, participants between and including the ages of 3 and 5 years will receive SOF based on their weight. Participants weighing ≥ 17 kg will receive 200 mg SOF (4 x 50 mg capsules containing granules) + RBV for 7 days and those weighing <17 kg will receive 150 mg SOF (3 X 50 mg capsules containing granules) + RBV for 7 days. Participants will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Drug: SOF (oral tablets)
SOF tablets administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: RBV
RBV administered as capsules or oral solution
Other Name: REBETOL®

Drug: SOF (oral granules)
SOF oral granule capsules administered orally once daily
Other Name: GS-7977

Experimental: SOF+RBV 12 weeks (Genotype 2, Group 1)
During the Treatment Phase, participants between and including the ages of 12 and 17 years old with genotype 2 HCV infection will receive SOF (400 mg: 1 x 400 mg, or 4 x 100 mg) + RBV for 12 weeks. If participants are unable to swallow SOF tablets, they will receive SOF oral granules (400 mg: 8 x 50 mg). Participants will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Drug: SOF (oral tablets)
SOF tablets administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: RBV
RBV administered as capsules or oral solution
Other Name: REBETOL®

Drug: SOF (oral granules)
SOF oral granule capsules administered orally once daily
Other Name: GS-7977

Experimental: SOF+RBV 12 weeks (Genotype 2, Group 2)
During the Treatment Phase, participants between and including the ages of 6 and 11 years old with genotype 2 HCV infection will receive SOF (200 mg: 2 x 100 mg) + RBV for 12 weeks. If participants are unable to swallow SOF tablets, they will receive SOF oral granules (200 mg: 4 x 50 mg). Participants between and including the ages of 3 and 5 will receive SOF based based on their weight. Participants weighing ≥ 17kg will receive 200 mg SOF (4 x 50 mg capsules containing granules) + RBV for 7 days and those weighing < 17kg will receive 150 mg SOF (3 x 50 mg capsules containing granules) + RBV for 7 days. Participants will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Drug: SOF (oral tablets)
SOF tablets administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: RBV
RBV administered as capsules or oral solution
Other Name: REBETOL®

Drug: SOF (oral granules)
SOF oral granule capsules administered orally once daily
Other Name: GS-7977

Experimental: SOF+RBV 24 weeks (Genotype 3, Group 1)
During the Treatment Phase, participants between and including the ages of 12 and 17 years old with genotype 3 HCV infection will receive SOF tablets (400 mg: 4 x 100 mg) + RBV for 24 weeks. If participants are unable to swallow SOF tablets, they will receive SOF oral granules (400 mg: 8 x 50 mg). Participants will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Drug: SOF (oral tablets)
SOF tablets administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: RBV
RBV administered as capsules or oral solution
Other Name: REBETOL®

Drug: SOF (oral granules)
SOF oral granule capsules administered orally once daily
Other Name: GS-7977

Experimental: SOF+RBV 24 weeks (Genotype 3, Group 2)
During the Treatment Phase, participants between and including the ages of 6 and 11 years old with genotype 3 HCV infection will receive SOF (200 mg: 2 x 100 mg) + RBV for 24 weeks. If participants are unable to swallow SOF tablets, they will receive SOF oral granules (200 mg: 4 x 50 mg). Participants between and including the ages of 3 and 5 will receive SOF based based on their weight. Participants weighing ≥ 17kg will receive 200 mg SOF (4 x 50 mg capsules containing granules) and those weighing < 17 kg will receive 150 mg SOF. All participants between the ages of 3 and 5 will receive SOF oral granules (3 x 50 mg capsules containing granules). Participants between and including the ages of 3 and 11 years old will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Drug: SOF (oral tablets)
SOF tablets administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: RBV
RBV administered as capsules or oral solution
Other Name: REBETOL®

Drug: SOF (oral granules)
SOF oral granule capsules administered orally once daily
Other Name: GS-7977




Primary Outcome Measures :
  1. PK Lead-in Phase: PK parameters of GS-331007 as measured by AUCtau for determining the appropriate SOF dose [ Time Frame: Day 7 ]
    AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)

  2. Treatment Phase: proportion of participants achieving SVR12 [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

  3. Treatment Phase: incidence of any adverse event leading to permanent discontinuation of study drug(s) [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. PK Lead-in Phase: change from baseline in HCV RNA [ Time Frame: Up to 7 days ]
  2. PK Lead-in Phase: incidence of adverse events leading to permanent discontinuation of study drug(s) [ Time Frame: Up to 7 days ]
  3. Treatment Phase: proportion of participants achieving SVR4 [ Time Frame: Posttreatment Week 4 ]
    SVR4 is defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.

  4. Treatment Phase: proportion of participants achieving SVR24 [ Time Frame: Posttreatment Week 24 ]
    SVR24 is defined as HCV RNA < LLOQ at 24 weeks following the last dose of study drug.

  5. Treatment Phase: proportion of participants with virologic breakthrough [ Time Frame: Up to 24 weeks ]
    Viral breakthrough is defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.

  6. Treatment Phase: proportion of participants with virologic relapse [ Time Frame: End of treatment to posttreatment Week 24 ]
    Viral relapse is defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment.

  7. Palatability of SOF oral granules [ Time Frame: Day 1 ]
  8. Treatment Phase: growth and development measurements as assessed by height [ Time Frame: Up to 24 weeks ]
  9. Treatment Phase: growth and development measurements as assessed by weight [ Time Frame: Up to 24 weeks ]
  10. Treatment Phase: growth and development measurements as assessed by Tanner Stage Assessment [ Time Frame: Up to 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Consent of parent or legal guardian required
  • Chronic HCV infection genotype 2 or 3
  • Screening laboratory values within defined thresholds
  • PK Lead-in only: all individuals must be treatment naive

Key Exclusion Criteria:

  • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
  • Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
  • Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
  • Pregnant or nursing females
  • Known hypersensitivity to study medication
  • Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


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): NCT02175758


  Show 36 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02175758     History of Changes
Other Study ID Numbers: GS-US-334-1112
2014-002283-32 ( EudraCT Number )
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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