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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Recurrence Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fundacion de Investigacion de Diego, San Juan, Puerto Rico

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Omega DUROS device

Drug

Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks

Primary outcomes

Safety

Time frame: Week 52

Sponsors and collaborators

Lead sponsor

Intarcia Therapeutics

Industry

Registry information

Official study title

Phase Ib Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Omega DUROS® and Ribavirin in Subjects With Chronic Hepatitis C Previously Treated With Pegylated Interferon and Ribavirin

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Aug 23, 2007
Registry last updated: Jun 8, 2011

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.

Published trials that share one or more normalized conditions with this study.

Completed