A pilot phase II open-label study of oglufanide disodium in patients with chronic hepatitis C

Phase 2

Completed

• Conditions: Chronic hepatitis C; Infection - Other infectious diseases

• Registration Number: ACTRN12607000418471
• Lead Sponsor: Implicit Bioscience Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Serological evidence of infection with hepatitis C virus (HCV), including anti-HCV antibodies and viral load at least 100 time sgreate tha the lower limit of detection.

Exclusion Criteria

1. Co-infection with hepatitis B or human immunodeficiency virus (HIV)
2. Severe liver disease, or liver disease due to other disorders
3. Renal, hepatic or bone marrow dysfunction
4. Active or suspected cancer or histor of malignancy with high risk of recurrence
5. Organ transplant
6. Substance abuse
7. Women of childbearing potential

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perecentage with greater than 2-log reduction in viral load.[4 weeks]

Secondary Outcome Measures

Name	Time	Method
1. Duration of response[Based on measurement of viral load at 4-weekly intervals];2. % with sustained viral response[At 12 and 24 weeks after the start of treatment.];3. % of patients with greater than 2-fold reduction in serum transaminases[at any time after the start of treatment]