NL-OMON45955
Completed
Phase 3
A randomised study of interferon-free treatment for recently acquired hepatitis C in people who inject drugs and people with HIV coinfection. - REACT
The Kirby Institute, The University of New South Wales Australia0 sites28 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Inflammation of the liver caused by a virus
- Sponsor
- The Kirby Institute, The University of New South Wales Australia
- Enrollment
- 28
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following inclusion criteria to be eligible to participate in this study. ;1 Participants have voluntarily signed the informed consent form.
- •2 18 years of age or older.
- •3 Detectable HCV RNA at screening (\>10,000 IU/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance
- •4 HCV genotypes 1\-6\.
- •5 HBsAg negative
- •6 Negative pregnancy test at baseline (females of childbearing potential only).
- •7 Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •8 Medically stable on the basis of physical examination, medical history and vital signs
- •9 Adequate literacy to provide reliable responses to the study questionnaires
- •10 All fertile males and females must be using effective contraception during treatment and during the 30 days after treatment end.
Exclusion Criteria
- •Subjects who meet any of the exclusion criteria are not to be enrolled in this study.;1 History of any of the following:
- •a. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
- •b. History of chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- •c. Solid organ transplant
- •d. Malignancy within 5 years prior to screening, with exception of specific cancers that may have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are also excluded.
- •e. Significant drug allergy (such as anaphylaxis or hepatotoxicity)
- •2\. Subject has a known or documented prior history of cirrhosis
- •3 Subject shows evidence of significant liver disease in addition to hepatitis C, which may include but is not limited to drug\- or alcohol\-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson\*s disease, non\-alcoholic steatohepatitis (NASH), or primary biliary cirrhosis
- •4 Any of the following lab parameters at screening:
- •a. Direct bilirubin \> 1\.5 x ULN
Outcomes
Primary Outcomes
Not specified
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