Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin

Completed · Phase 1/Phase 2

Conditions studied: Healthy Volunteers, Hepatitis C Virus

In brief

This is an adaptive Phase I study to evaluate RO5024048 in the following groups: * Healthy Volunteers (Part 1 - Single Ascending Dose Study) -Enrollment completed * Hepatitis C virus (HCV) genotype 1 infected patients who have failed interferon therapy (Part 2- Multiple Ascending Dose Study)-Enrollment Completed * HCV genotype 1-infected patients who are treatment naive, to be dosed in combination with PEG-IFN and RBV (Part 3 - Combination Dose Study)-Currently Enrolling * HCV genotype 2-3 infected patients who have previously been treated with interferon but who did not respond, to be dosed in combination with PEG-IFN and RBV (Part 3 - Combination Dose Study)- Currently enrolling The study aims to determine if RO5024048 is safe and well-tolerated in healthy people and in people infected with hepatitis C virus. The amount of RO5024048 in the blood will be measured during the study and the amount of hepatitis C virus in the blood after each dose will also be measured. During Part 3 of the study, RO5024048 will be given with PEG-IFN and RBV, two drugs currently used and approved for the treatment of HCV.

Key facts

Study ID

NCT00382798

Run by

Pharmasset

People needed

75

Starts

2006-10-01

Expected to finish

2008-09-01

Last updated by the study team

2009-04-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Positive test at Screening for HAV, HBV, or HIV.
• History or other evidence of a medical condition associated with chronic liver disease, decompensated liver disease, renal disease, immunologically mediated disease, chronic pulmonary disease, cardiac disease, thyroid disease, severe retinopathy, severe psychiatric disease, organ transplantation, cancer, seizure disorder, or pancreatitis.
• Abnormal hematological, biochemical, or coagulation parameters at Screening; or positive fecal occult blood test.
• Estimated creatinine clearance of 90 mL/minute or less at Screening.
• Poorly controlled hypertension, or anyone who at screening or baseline has a BP of 140/90 or greater.
• Type 1 or 2 diabetics with hemoglobin A1C > 7.
• A baseline increased risk for anemia.
• Screening ECG QTc value ≥ 450 ms and/or clinically significant ECG findings.
• Positive results for drugs of abuse at Screening.
• History of clinically significant drug allergy to nucleoside/nucleotide analogues.
• Donation or loss of more than 400 mL blood within 2 months prior to anticipated dose administration.
• Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to anticipated dose administration.
• Males whose female partner is pregnant.
• Any chronic viral (including HSV), bacterial, mycobacterial, fungal, parasitic, or protozoal infection.
• Serum alpha-feto-protein > 50 ng/mL at screening.
• Receipt of any vaccination within 30 days prior to anticipated dose administration.

Where it is running

• Quest Clinical Research — San Francisco, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Duke Clinical Research Institute — Durham, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Auckland Clinical Studies Limited — Grafton, Auckland, New Zealand
• Fundacion de Investigacion de Diego — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.