Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment

Intarcia Therapeutics

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: Omega DUROS device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519792

ITCA 638-CLP-08

Details and patient eligibility

About

Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days.

This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Hepatitis C with HCV genotype 1 infection
• Relapse following an end of treatment response after treatment with a pegylated interferon and ribavirin.

Exclusion criteria

• Presence or history of non-HCV chronic liver disease
• Treatment with any interferon subsequent to the relapse with pegylated interferon-alpha and ribavirin
• Decompensated liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Experimental group

Description:

Omega DUROS: Dose 25

Treatment:

Drug: Omega DUROS device

2

Experimental group

Description:

Omega DUROS: Dose 50

Treatment:

Drug: Omega DUROS device