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 - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00851890

Purpose

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-333 in treatment-naïve HCV infected subjects.

Condition	Intervention	Phase
HCV Infection	Drug: ABT-333 Drug: Placebo Drug: peginterferon alfa-2a Drug: Ribavirin	Phase II

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Resource links provided by NLM:

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	30
Study Start Date:	April 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 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	Drug: ABT-333 Capsule for Arms 1,2,3 and Tablet for Arms 4,5,6; see arms for intervention description Drug: Placebo Capsule for Arms 1,2,3 and Tablet for Arms 4,5,6; see arms for intervention description Drug: peginterferon alfa-2a Syringe, 180 mcg/0.5mL Drug: Ribavirin 200 mg Tablet dosed at 1000 to 1200 mg total daily dose divided BID (adjusted based on body weight)
2 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	Drug: ABT-333 Capsule for Arms 1,2,3 and Tablet for Arms 4,5,6; see arms for intervention description Drug: Placebo Capsule for Arms 1,2,3 and Tablet for Arms 4,5,6; see arms for intervention description Drug: peginterferon alfa-2a Syringe, 180 mcg/0.5mL Drug: Ribavirin 200 mg Tablet dosed at 1000 to 1200 mg total daily dose divided BID (adjusted based on body weight)
3 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	Drug: ABT-333 Capsule for Arms 1,2,3 and Tablet for Arms 4,5,6; see arms for intervention description Drug: Placebo Capsule for Arms 1,2,3 and Tablet for Arms 4,5,6; see arms for intervention description Drug: peginterferon alfa-2a Syringe, 180 mcg/0.5mL Drug: Ribavirin 200 mg Tablet dosed at 1000 to 1200 mg total daily dose divided BID (adjusted based on body weight)
4 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	Drug: ABT-333 Capsule for Arms 1,2,3 and Tablet for Arms 4,5,6; see arms for intervention description Drug: Placebo Capsule for Arms 1,2,3 and Tablet for Arms 4,5,6; see arms for intervention description Drug: peginterferon alfa-2a Syringe, 180 mcg/0.5mL Drug: Ribavirin 200 mg Tablet dosed at 1000 to 1200 mg total daily dose divided BID (adjusted based on body weight)
5 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	Drug: ABT-333 Capsule for Arms 1,2,3 and Tablet for Arms 4,5,6; see arms for intervention description Drug: Placebo Capsule for Arms 1,2,3 and Tablet for Arms 4,5,6; see arms for intervention description Drug: peginterferon alfa-2a Syringe, 180 mcg/0.5mL Drug: Ribavirin 200 mg Tablet dosed at 1000 to 1200 mg total daily dose divided BID (adjusted based on body weight)
6 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	Drug: ABT-333 Capsule for Arms 1,2,3 and Tablet for Arms 4,5,6; see arms for intervention description Drug: Placebo Capsule for Arms 1,2,3 and Tablet for Arms 4,5,6; see arms for intervention description Drug: peginterferon alfa-2a Syringe, 180 mcg/0.5mL Drug: Ribavirin 200 mg Tablet dosed at 1000 to 1200 mg total daily dose divided BID (adjusted based on body weight)

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851890

Locations

United States, Illinois
Global Medical Information Services
Abbott Park, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Daniel Cohen, MD/Study Medical Director )
Study ID Numbers:	M10-380
Study First Received:	February 24, 2009
Last Updated:	July 24, 2009
ClinicalTrials.gov Identifier:	NCT00851890 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Virus Diseases
Hepatitis
Anti-Infective Agents
Hepatitis, Chronic
Interferons

Ribavirin
Peginterferon alfa-2a
Hepatitis C
Antiviral Agents
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Ribavirin
Peginterferon alfa-2a
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009