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GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01353248
First received: April 22, 2011
Last updated: November 26, 2013
Last verified: November 2013

April 22, 2011
November 26, 2013
May 2011
October 2012   (final data collection date for primary outcome measure)
Sustained virologic response (SVR) [ Time Frame: 24 weeks of off-treatment follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01353248 on ClinicalTrials.gov Archive Site
  • Safety and tolerability [ Time Frame: through 24 weeks of off-treatment follow-up ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of 30 mg or 90 mg GS-5885 when given with GS-9451, Tegobuvir and RBV for 12 or 24 weeks. Safety endpoints will be analyzed by the number and percent of subjects with events or abnormalities for categorical values or 8-number summary (n, mean, standard deviation, median, Q1, Q3, minimum, maximum) for continuous data by treatment group.
  • HCV RNA < Lower Limit Of Quantification [ Time Frame: Weeks 1, 2, 4, 12 and 24 ] [ Designated as safety issue: No ]
    To evaluate the antiviral efficacy at Weeks 1, 2, 4, 12 and 24, as measured by the rates of HCV RNA < LLoQ and viral breakthrough and relapse.
  • Rescue Therapy Substudy SVR [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    To evaluate the antiviral efficacy (as defined by SVR) of the addition of pegylated interferon (PEG) for 24 weeks to GS-5885, GS-9451, tegobuvir and RBV in subjects who experience viral breakthrough on treatment.
  • Emergence of viral resistance [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: No ]
    To evaluate the emergence of viral resistance during treatment with GS-9451, Tegobuvir and RBV when given with 30 mg or 90 mg GS-5885 for 12 or 24 weeks.
  • Viral dynamics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV [ Time Frame: Through Week 2 of therapy ] [ Designated as safety issue: No ]
    HCV RNA levels, pharmacokinetics and viral sequencing
  • Pharmacokinetics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV [ Time Frame: Through Week 2 of therapy ] [ Designated as safety issue: No ]

    Pharmacokinetics (Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau, and T½) will be listed

    and summarized for GS-5885, GS-9451 and Tegobuvir using descriptive statistics (e.g.,

    sample size, arithmetic mean, geometric mean, % coefficient of variation, standard deviation,

    median, minimum, and maximum). Plasma concentrations of the study drug over time will be

    summarized using descriptive statistics

  • Safety and tolerability [ Time Frame: through 24 weeks of off-treatment follow-up ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of 30 mg or 90 mg GS-5885 when given with GS-9451, tegobuvir and RBV for 12 or 24 weeks. Safety endpoints will be analyzed by the number and percent of subjects with events or abnormalities for categorical values or 8-number summary (n, mean, standard deviation, median, Q1, Q3, minimum, maximum) for continuous data by treatment group.
  • HCV RNA < Lower Limit Of Quantification [ Time Frame: Weeks 1, 2, 4, 12 and 24 ] [ Designated as safety issue: No ]
    To evaluate the antiviral efficacy at Weeks 1, 2, 4, 12 and 24, as measured by the rates of HCV RNA < LLoQ and viral breakthrough and relapse.
  • Rescue Therapy Substudy SVR [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    To evaluate the antiviral efficacy (as defined by SVR) of the addition of pegylated interferon (PEG) for 24 weeks to GS-5885, GS-9451, tegobuvir and RBV in subjects who experience viral breakthrough on treatment.
  • Emergence of viral resistance [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: No ]
    To evaluate the emergence of viral resistance during treatment with GS-9451, tegobuvir and RBV when given with 30 mg or 90 mg GS-5885 for 12 or 24 weeks.
  • Viral dynamics of GS-5885, GS-9451 and tegobuvir when administered in combination with RBV [ Time Frame: Through Week 2 of therapy ] [ Designated as safety issue: No ]
    HCV RNA levels, pharmacokinetics and viral sequencing
  • Pharmacokinetics of GS-5885, GS-9451 and tegobuvir when administered in combination with RBV [ Time Frame: Through Week 2 of therapy ]

    Pharmacokinetics (Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau, and T½) will be listed

    and summarized for GS-5885, GS-9451 and Tegobuvir using descriptive statistics (e.g.,

    sample size, arithmetic mean, geometric mean, % coefficient of variation, standard deviation,

    median, minimum, and maximum). Plasma concentrations of the study drug over time will be

    summarized using descriptive statistics

Not Provided
Not Provided
 
GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection

The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 HCV Infection.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: GS-5885
    tablet, 30 mg QD
  • Drug: Tegobuvir
    capsule, 30 mg BID
  • Drug: GS-9451
    tablet, 200 mg QD
  • Drug: ribavirin tablet
    (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
  • Drug: GS-5885
    tablet, 90 mg QD
  • Active Comparator: Arm 1
    GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks.
    Interventions:
    • Drug: GS-5885
    • Drug: Tegobuvir
    • Drug: GS-9451
    • Drug: ribavirin tablet
  • Active Comparator: Arm 2
    GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks.
    Interventions:
    • Drug: Tegobuvir
    • Drug: GS-9451
    • Drug: ribavirin tablet
    • Drug: GS-5885
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
March 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult subjects 18 to 70 years of age
  • Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
  • Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
  • Monoinfection with HCV genotype 1a or 1b
  • HCV treatment-naïve
  • Body mass index (BMI) between 18 and 36 kg/m2
  • Creatinine clearance ≥ 50 mL/min
  • Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
  • Screening laboratory values within defined thresholds

Exclusion Criteria:

  • Autoimmune disease
  • Decompensated liver disease or cirrhosis
  • Poorly controlled diabetes mellitus
  • Severe psychiatric illness
  • Severe chronic obstructive pulmonary disease (COPD)
  • Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
  • Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
  • History of hemoglobinopathy
  • Known retinal disease
  • Subjects who are immunosuppressed
  • Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
  • Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01353248
GS-US-248-0120
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Benedetta Massetto, MD, PhD Gilead Sciences
Gilead Sciences
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP