A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	February 24, 2009
Last Updated Date	April 29, 2009
Start Date ^†	April 2009
Current Primary Outcome Measures ^† (submitted: February 25, 2009)	Analysis of pharmacokinetic variables and antiviral activity in treatment-naïve HCV-infected subjects. [ Time Frame: Approximately 4 weeks. ] [ Designated as safety issue: No ] Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs. [ Time Frame: Approximately 4 weeks. ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00851890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: February 25, 2009)	Assess emergence of resistant virus in conjunction with kinetics of viral load decay and rebound in treatment-naïve HCV-infected subjects. [ Time Frame: Approximately 4 weeks. ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Official Title ^†
Brief Summary	The purpose of this study is to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-333 in treatment-naïve HCV infected subjects.
Detailed Description	Phase 2a, blinded, randomized, placebo-controlled clinical trial in HCV infected adults to evaluate safety, tolerability, antiviral activity and pharmacokinetics of ABT-333 or placebo monotherapy followed by 26 days of ABT-333 or placebo with pegIFN and RBV combination therapy. The study will also assess emergence of resistant virus in conjunction with kinetics of viral load decay and rebound in treatment-naïve HCV-infected subjects.
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Other, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Condition ^†	HCV Infection
Intervention ^†	Drug: ABT-333 Drug: Placebo Drug: peginterferon alfa-2a Drug: Ribavirin
Study Arms / Comparison Groups	Other: Groups 1 and 2: HCV+ treatment-naive subjects, receiving 300mg ABT-333 or placebo, BID for 2 days followed by 300mg ABT-333 or placebo BID with pegIFN and RBV for 26 days Other: Groups 3 and 4: HCV+ treatment-naive subjects, receiving 600mg ABT-333 or placebo, BID for 2 days followed by 600mg ABT-333 or placebo BID with pegIFN and RBV for 26 days Other: Groups 5 and 6: HCV+ treatment-naive subjects, receiving 1200mg ABT-333 or placebo, QD for 2 days followed by 1200mg ABT-333 or placebo QD with pegIFN and RBV for 26 days Other: Groups 7 and 8: HCV+ treatment-naive subjects, receiving 1200mg ABT-333 or placebo, BID for 2 days followed by 1200mg ABT-333 or placebo BID with pegIFN and RBV for 26 days Other: Groups 9 and 11: HCV+ treatment-naive subjects, receiving 2400mg ABT-333 or placebo, QD for 2 days followed by 2400mg ABT-333 or placebo QD with pegIFN and RBV for 26 days Group 10: HCV+ treatment-naive subjects, receiving placebo for 2 days followed by 2400mg ABT-333 or placebo QD with pegIFN and RBV for 26 days Other: Groups 12 and 13: HCV+ treatment-naive subjects, receiving 1600mg ABT-333 or placebo, BID for 2 days followed by 1600mg ABT-333 or placebo BID with pegIFN and RBV for 26 days
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Enrolling by invitation
Enrollment ^†	68
Completion Date
Estimated Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	Inclusion Criteria: Main Selection Criteria: Subject has provided written consent. If female, subject is postmenopausal or surgically sterile. If male, must be practicing two effective methods of birth control. Subject is HCV genotype 1 with HCV RNA of >50,000 IU/mL. Subjects must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment. Subjects must have a liver biopsy with histology consistent with HCV induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV. Condition of general good health other then HCV infection. Subjects with a history of thyroid disease must have a TSH value in the normal range. Exclusion Criteria: Main Selection Criteria: No prior history of receiving therapy for HCV infection. Positive test result for HAV-IgM, HBsAg, or HIV Ab. Pregnant or breastfeeding females or male partners of women who are pregnant. History of seizures or cancer. History of major depressive disorder within 2 years. Any current or past history of cirrhosis. Any cause of liver disease other than chronic HCV infection.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00851890
Responsible Party	Daniel Cohen, MD/Study Medical Director, Abbott
Secondary IDs ^††
Study Sponsor ^†	Abbott
Collaborators ^††
Investigators ^†
Information Provided By	Abbott
Verification Date	April 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.