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A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01371162
First received: June 6, 2011
Last updated: November 24, 2014
Last verified: November 2014

June 6, 2011
November 24, 2014
June 2011
December 2011   (final data collection date for primary outcome measure)
  • Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test) [ Time Frame: up to 17 days ] [ Designated as safety issue: No ]
  • Parts A + B: Safety: Incidence of adverse events [ Time Frame: up to 24 days ] [ Designated as safety issue: No ]
  • Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC) [ Time Frame: up to 24 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01371162 on ClinicalTrials.gov Archive Site
Part B: Viral resistance (viral breakthrough/non-response/partial response) HCV RNA assessed by Roche COBAS Paqman HCV Test [ Time Frame: up to 17 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of the HCV Nucleoside Inhibitor RO5428029 in Healthy Subjects and in CHC Genotype 1 Infected Patients

This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or u p to 14 days (healthy volunteers).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Hepatitis C, Chronic, Healthy Volunteer
  • Drug: RO5428029
    Multiple ascending doses
  • Drug: placebo
    multiple doses
  • Experimental: A1 Healthy Volunteers
    Intervention: Drug: RO5428029
  • Placebo Comparator: A2
    Intervention: Drug: placebo
  • Experimental: B1 HCV Infection
    Intervention: Drug: RO5428029
  • Placebo Comparator: B2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects (Part A) or patients with chronic hepatitis C infection (Part B), 18 to 60 years of age, inclusive
  • Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg
  • Female subjects/patients must be surgically sterile or post-menopausal
  • Male subjects/patients and their partners of childbearing potential must use 2 methods of contraception
  • For HCV patients:
  • Hepatitis C genotype 1 of > 6 months duration at screening
  • HCV RNA quantifiable (Roche COBAS TaqMan HCV Test) at screening
  • HCV treatment-naïve (no prior antiviral therapy for chronic hepatitis C with interferon-based therapy)
  • Liver biopsy or non-invasive procedure within the past 2 years showing absence of cirrhosis

Exclusion Criteria:

  • Pregnant or lactating women, and male partners of women who are pregnant or lactating
  • Positive test for drugs of abuse
  • History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams or 1 unit of alcohol
  • History or symptoms of any significant disease or disorder
  • History of active malignancy within the last 5 years, except for localized or in situ carcinoma (e.g. basal or squamous cell carcinoma of the skin)
  • Positive for hepatitis B or HIV infection, and/ or for HCV for healthy volunteers (Part A)
  • For HCV patients:
  • Decompensated liver disease or impaired liver function as defined by any history of ascites, hepatic encephalopathy, hepatocellular carcinoma or bleeding esophageal varices, or prothrombin international normalized ratio (PTINR) >/= 2.0 at screening
  • Evidence of cirrhosis and/or incomplete transition to cirrhosis
  • Presence or history of non-hepatitis C liver disease
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Netherlands,   Poland
 
NCT01371162
NP25733
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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