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

In patients with chronic hepatitis C, does treatment with oglufanide disodium reduce viral load from baseline value?

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000418471

Enrollment

Registered

2007-08-17

Start date

2007-08-08

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The primary purpose of the study is to assess the efficacy of the drug in reducing viral load in patients with chronic HCV infection

Interventions

Intranasal oglufanide disodium 0.05 mg twice daily for 21 days

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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

Outcome results