NCT00978497

Brief Summary

The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598 when administered with pegylated interferon and ribavirin (Standard of Care \[SOC\]) compared to placebo + SOC.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2009

Geographic Reach
2 countries

21 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

September 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

September 16, 2009

Last Update Submit

March 29, 2017

Conditions

HCV Infection

Outcome Measures

Primary Outcomes (1)

  • Undetectable HCV RNA

    12 Weeks

Secondary Outcomes (4)

  • Safety and Tolerability

    Throughout study

  • Undetectable HCV RNA

    Week 4, Week 24, and Week 48

  • ANA598, Peg-IFN-a-2-a, ribavirin concentrations

    Various time points through Week 12

  • Undetectable HCV RNA

    24 weeks after completion of therapy for sustained virologic response [SVR]

Study Arms (3)

1

PLACEBO COMPARATOR

Peginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks

Drug: placeboDrug: PeginterferonDrug: Ribavirin

2

EXPERIMENTAL

ANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks

Drug: ANA598Drug: PeginterferonDrug: Ribavirin

3

EXPERIMENTAL

ANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks

Drug: ANA598Drug: PeginterferonDrug: Ribavirin

Interventions

placeboDRUG

oral BID

1
ANA598DRUG

oral 200mg BID

2
PeginterferonDRUG

180 μg dose via subcutaneous injection weekly

123
RibavirinDRUG

oral 1000 mg/day for patients who weighed \< 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg

123

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

You may not qualify if:

  • Female patients who are pregnant or breast-feeding
  • Infection with non-genotype 1 HCV
  • Previous treatment for HCV infection
  • HIV or HBV positive
  • Any medical contraindication to Peg-IFN or RBV therapy
  • History of any other known cause of liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

United States, California 1

Anaheim, California, 92801, United States

Location

United States, California 4

Los Angeles, California, 90048, United States

Location

United States, California 2

San Clemente, California, 92673, United States

Location

United States, California 3

San Diego, California, 92120, United States

Location

United States, California 5

San Francisco, California, 33136, United States

Location

United States, Florida 2

Gainesville, Florida, 32601, United States

Location

United States, Florida 3

Miami, Florida, 33136, United States

Location

United States, Florida 1

Sarasota, Florida, 34209, United States

Location

United States, Maryland

Lutherville, Maryland, 21093, United States

Location

United States, Massachusetts

Boston, Massachusetts, 02215, United States

Location

United States, Michigan

Detroit, Michigan, 48202, United States

Location

United States, New York

New York, New York, 10021, United States

Location

United States, North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

United States, North Carolina

Durham, North Carolina, 27705, United States

Location

United States, Ohio

Cincinnati, Ohio, 45267, United States

Location

United States, Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

United States, Texas 2

Houston, Texas, 77073, United States

Location

United States, Texas 1

San Antonio, Texas, 78215, United States

Location

United States, Virginia 1

Fairfax, Virginia, 22031, United States

Location

United States, Virginia 2

Falls Church, Virginia, 22042, United States

Location

Puerto Rico

Santurce, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

setrobuvirRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 2
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

September 16, 2009

First Posted

September 17, 2009

Study Start

September 1, 2009

Primary Completion

April 1, 2010

Study Completion

August 1, 2011

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations

US(20)PR(1)