NCT00782353

Brief Summary

The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

October 28, 2008

Last Update Submit

November 12, 2012

Conditions

Chronic Hepatitis C

Keywords

HCV

Outcome Measures

Primary Outcomes (2)

  • The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease;

    10 days

  • The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels

    10 days

Study Arms (3)

Cohort 1

EXPERIMENTAL

Subjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid

Drug: ANA598 200 mg bid or placebo

Cohort 2

EXPERIMENTAL

Subjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid

Drug: ANA598 400 mg bid or placebo

Cohort 3

EXPERIMENTAL

Subjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid

Drug: ANA598 800 mg bid or placebo

Interventions

ANA598 200 mg bid or placeboDRUG

ANA598 200 mg bid or placebo

Cohort 1
ANA598 400 mg bid or placeboDRUG

ANA598 400 mg bid or placebo

Cohort 2
ANA598 800 mg bid or placeboDRUG

ANA598 800 mg bid or placebo

Cohort 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, ages 18 to 65 years
  • Documented chronic HCV infection, genotype 1a or 1b
  • Treatment-naïve
  • BMI = 18 - 35 kg/m2

You may not qualify if:

  • Female patients who are pregnant or breast-feeding
  • Previous treatment for HCV infection
  • HIV or HBV positive
  • Evidence of cirrhosis on previous liver biopsy or on previous imaging studies
  • History of any other known cause of liver disease;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

United States, Missouri

St Louis, Missouri, 63104, United States

Location

United States, New York

New York, New York, 10021, United States

Location

United States, Texas

San Antonio, Texas, 78215, United States

Location

Puerto Rico, Santurce

Santurce, 00909, Puerto Rico

Location

Related Publications (1)

  • Mallalieu NL, Rahimy MH, Crowley CA, Appleman JR, Smith PF, Freddo JL. Pharmacokinetics and pharmacodynamics of setrobuvir, an orally administered hepatitis C virus non-nucleoside analogue inhibitor. Clin Ther. 2014 Dec 1;36(12):2047-2063.e3. doi: 10.1016/j.clinthera.2014.10.002. Epub 2014 Nov 4.

    PMID: 25456558DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

setrobuvirBID protein, human

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2008

First Posted

October 31, 2008

Study Start

October 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

PR(1)US(3)