ACTRN12612000828820
Completed
Phase 2
A Phase 2a, Placebo-Controlled, Randomised Study of the Safety, Pharmacokinetics and Antiviral Activity of BIT225 in Combination with Pegylated Interferon and Ribavirin in Patients with Hepatitis C Virus Infection.
Biotron Limited0 sites24 target enrollmentAugust 7, 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hepatitis C Virus Infection
- Sponsor
- Biotron Limited
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males or females, aged 18 to 55 years
- •2\. Chronic hepatitis C infection (defined as persistent HCV infection as diagnosed by detection of HCV RNA in the blood at least 6 months from initial detection).
- •3\. Serologic evidence of HCV infection by anti\-HCV antibody test.
- •4\. Documentation of HCV genotype 1\-infection at any time prior to entry. A laboratory report must be used for documentation. Those without known genotype at screening will have a screening genotype performed.
- •5\. HCV RNA of \>/\= 105 IU/mL as measured by the ROCHE COBAS Amplicor Monitor 'registered trademark' version 2\.0 method within 60 days of Entry
- •6\. ALT (SGOT) , AST (SGPT), and alkaline phosphatase less than or equal to 5 times upper level of normal within 60 days of Entry.
- •7\. For females of reproductive potential (defined as women who have not been post\-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy and/or tubal ligation), must have a negative serum or urine pregnancy test with a sensitivity of at least 50mlU/mL within 60 days prior to study entry.
- •A negative serum or urine pregnancy test result is also required within 24 hours prior to the initiation of study treatment (Day \-1\)
- •All subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization).
- •If participating in sexual activity that could lead to pregnancy, the subject must agree to use two reliable methods of contraception simultaneously while receiving study treatment and for 6 weeks after stopping study treatment.
Exclusion Criteria
- •1\. Patients who have received an investigational drug for HCV.
- •2\. Positive results for Hepatitis B (Hepatitis B surface antigen) and HIV antibody at Screening.
- •3\. History or presence of other evidence of a medical condition associated with chronic liver disease (e.g., chronic or acute hepatitis B, acute hepatitis A, hemochromatosis, autoimmune hepatitis, Wilson’s disease, Gilbert’s syndrome, homozygote alpha1\-antitrypsin deficiency, alcoholic liver disease, and toxin exposures).
- •4\. Bridging cirrhosis or cirrhosis confirmed on a biopsy obtained within the past 36 months as judged by a local pathologist. Note: patients with Metavir (or equivalent index) stage 3 fibrosis on a previous biopsy or patients with no previous biopsy will require an abdominal ultrasound within 6 months of first dose showing no evidence of cirrhosis
- •5\. History or signs of decompensated liver disease manifested by presence of Child\-Pugh class B or C, ascites, variceal bleeding, or hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency
- •6\. History or other evidence of clinically significant renal disease.
- •7\. Pregnancy or breast feeding, male partners of pregnant females.
- •8\. Abnormal haematological and biochemical parameters within 60 days of Entry:
- •a. Absolute neutrophil count \<1000/mm3
- •b. Haemoglobin \<11 g/dL in females or 13 g/dL in males
Outcomes
Primary Outcomes
Not specified
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