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A Phase 2a, Randomized, Open-Label Study in Patients with Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacodynamics, and Antiviral Activity of ANA773 Tosylaat Administered with Ribavirin

A Phase 2a, Randomized, Open-Label Study in Patients with Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacodynamics, and Antiviral Activity of ANA773 Tosylaat Administered with Ribavirin - ANA773 with ribavirin in chronic hepatitis C infected subjects

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35795
Enrollment
6
Registered
2011-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatitis C

Interventions

Medication: - 2000mg ANA773 tosylate for 26 or27 days, combined with ribavirin (bodyweight75 kg: 1200 mg)
-Standard of Care therapy: pegylated interferon (180 mcg) with ribavirin.

Sponsors

Anadys Therapeutics Inc.
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Hepatitis C, genotype 1 IL28B genotypic polymorphism CT naïve to or have relapsed from prior pegylated interferon-alpha based therapy Age between 18 - 65 year of each

Exclusion criteria

Exclusion criteria: Pregnant or lactating females; patient previously treated with experimental drugs for HCV

Design outcomes

Primary

MeasureTime frame
Pharmacodynamics: viral load Hepatitis C. Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)