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Completed

NCT Number: NCT00978497

Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection

The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598 when administered with pegylated interferon and ribavirin (Standard of Care [SOC]) compared to placebo + SOC.

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Key information

Conditions

HCV Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Puerto Rico, Santurce

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About this study

The safety, tolerability and antiviral activity of ANA598, administered orally at 200 mg BID or 400 mg BID for 12 weeks in combination with pegylated interferon and ribavirin (SOC) will be compared to placebo + SOC. Treatment-naïve patients with genotype 1 infection will be eligible for enrollment. Patients randomized to ANA598 will receive a loading dose of 800 mg q 12 hours administered on the first day of dosing. Patients with undetectable HCV RNA at week 4 and week 12 will be randomized to receive either an additional 12 or 36 weeks of SOC alone.

Ninety patients will be randomized into 2 cohorts. The forty-five patients in each cohort will be randomized as 30 active: 15 placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, ages 18 to 65 years
  • Documented chronic HCV infection, genotype 1a or 1b
  • Treatment-naïve

Exclusion criteria

  • Female patients who are pregnant or breast-feeding
  • Infection with non-genotype 1 HCV
  • Previous treatment for HCV infection
  • HIV or HBV positive
  • Any medical contraindication to Peg-IFN or RBV therapy
  • History of any other known cause of liver disease

Treatment and study plan

Placebo

Drug

oral BID

ANA598

Drug

oral 200mg BID

Peginterferon

Drug

180 μg dose via subcutaneous injection weekly

Ribavirin

Drug

oral 1000 mg/day for patients who weighed < 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg

Primary outcomes

  1. Undetectable HCV RNA

    Time frame: 12 Weeks

Secondary outcomes

  1. Safety and Tolerability

    Time frame: Throughout study

  2. Undetectable HCV RNA

    Time frame: Week 4, Week 24, and Week 48

  3. ANA598, Peg-IFN-a-2-a, ribavirin concentrations

    Time frame: Various time points through Week 12

  4. Undetectable HCV RNA

    Time frame: 24 weeks after completion of therapy for sustained virologic response [SVR]

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Trial of the Safety, Efficacy, and Pharmacokinetics of ANA598 Administered With Pegylated Interferon and Ribavirin in Treatment-Naïve Genotype 1 Patients With Chronic Hepatitis C Infection

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Sep 17, 2009
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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