NCT01165359

Brief Summary

Hepatitis C (HCV) is a disease that affects the liver. ITX 5061 is a new medication that is being tested to treat HCV. This study will evaluate the safety of ITX 5061 and examine different doses of the medication to evaluate which dose is the most effective at lowering the amount of HCV in the blood.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2010

Geographic Reach
2 countries

10 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

First Submitted

Initial submission to the registry

July 15, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

July 15, 2010

Last Update Submit

October 28, 2021

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

  • Reduction in serum HCV RNA level greater than or equal to 1 log10 IU/mL from baseline at the end of treatment

    Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)

  • Adverse events (AEs) greater than or equal to grade 3 attributed to the study treatment by the cohort review group

    Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)

Secondary Outcomes (3)

  • Pharmacokinetic parameters (area under the curve [AUC], Cmax, Cmin) for ITX 5061

    Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)

  • Quantitative change in HCV RNA from baseline at the study visits

    Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)

  • All reported AEs

    Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)

Study Arms (6)

Part A: ITX 5061

EXPERIMENTAL

Participants will receive ITX 5061 once a day for 3 days.

Drug: ITX 5061

Part A: Placebo

PLACEBO COMPARATOR

Participants will receive placebo once a day for 3 days.

Drug: Placebo ITX 5061

Part B: ITX 5061

EXPERIMENTAL

Participants will receive ITX 5061 once a day for 14 days.

Drug: ITX 5061

Part B: Placebo

PLACEBO COMPARATOR

Participants will receive placebo once a day for 14 days.

Drug: Placebo ITX 5061

Part C: ITX 5061

EXPERIMENTAL

Participants will receive ITX 5061 once a day for 28 days.

Drug: ITX 5061

Part C: Placebo

PLACEBO COMPARATOR

Participants will receive placebo once a day for 28 days.

Drug: Placebo ITX 5061

Interventions

ITX 5061DRUG

For Part A of the study: 150 mg of ITX 5061, once a day for 3 days; 75 mg of ITX 5061, once a day for 3 days; or 25 mg of ITX 5061, once a day for 3 days. For Part B of the study: 150 mg of ITX 5061, once a day for 14 days; 75 mg of ITX 5061, once a day for 14 days; or 25 mg of ITX 5061, once a day for 14 days. For Part C of the study: 150 mg of ITX 5061, once a day for 28 days; 75 mg of ITX 5061, once a day for 28 days; or 25 mg of ITX 5061, once a day for 28 days.

Part A: ITX 5061Part B: ITX 5061Part C: ITX 5061
Placebo ITX 5061DRUG

For Part A of the study: placebo, once a day for 3 days. For Part B of the study: placebo, once a day for 14 days. For Part C of the study: placebo, once a day for 28 days.

Part A: PlaceboPart B: PlaceboPart C: Placebo

Eligibility Criteria

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

You may qualify if:

  • Absence of HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit within 45 days prior to study entry
  • Chronic HCV infection as defined and documented by testing. See protocol for details.
  • HCV genotype 1 infection with source documentation from a College of American Pathologists (CAP) or Clinical Laboratory Improvement Amendments (CLIA) approved laboratory (or its equivalent) within 1 year prior to study entry. Those without a documented genotype result at screening will have a screening genotype performed either locally or provided by the study as described in the protocol.
  • Serum or plasma HCV RNA greater than or equal to 100,000 IU/mL (5 log10) obtained within 45 days prior to study entry by any laboratory that has a CLIA certification or its equivalent
  • Lack of significant hepatic fibrosis (bridging fibrosis or cirrhosis) confirmed by biopsy within 2 years of study entry or HCV FibroSURE score of less than or equal to METAVIR stage 2 within 1 year of study entry
  • The following laboratory values obtained within 45 days prior to study entry:
  • White blood cell (WBC) count greater than or equal to 3000/mm3
  • Absolute neutrophil count (ANC) greater than or equal to 1000/mm3
  • Hemoglobin greater than or equal to 12 g/dL for men and greater than or equal to 11 g/dL for women
  • Platelet count greater than or equal to 120,000/mm3
  • Alanine aminotransferase (ALT) less than or equal to 5 x the upper limit of normal (ULN)
  • International normalized ratio (INR) less than 1.5
  • Total bilirubin less than or equal to ULN
  • Calculated creatinine clearance (CrCl) greater than or equal to 80 mL/min, as estimated by the Cockcroft-Gault equation. More information on this criterion can be found in the protocol.
  • Hemoglobin A1c (HbA1c) less than or equal to 8.5% for participants with diabetes; must be obtained within 90 days prior to study entry
  • +5 more criteria

You may not qualify if:

  • Prior receipt of any interferon or ribavirin (RBV)
  • Prior receipt of any therapy for HCV, including experimental treatments
  • Evidence of decompensated liver disease manifested by presence of or history of ascites, variceal bleeding, or hepatic encephalopathy
  • History of Gilbert's syndrome
  • Presence of other known causes of significant liver disease including chronic or acute hepatitis B, acute hepatitis A, hemochromatosis, or homozygote alpha-1 antitrypsin deficiency
  • History of known hepatocellular carcinoma
  • History of major organ transplantation with an existing functional graft
  • History of uncontrolled seizure disorders
  • Breastfeeding
  • Use of prohibited medications within 14 days prior to study entry. More information on this criterion can be found in the protocol.
  • Initiation or change in dose of any nonprohibited prescription medication within 14 days prior to study entry
  • Known allergy/sensitivity or any hypersensitivity to components of study drug or its formulation
  • Any condition including active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Serious illness requiring systemic treatment and/or hospitalization within 24 weeks prior to study entry; serious illness including malignancy, active coronary artery disease within 24 weeks prior to study entry; other chronic medical conditions that may preclude completion of the study in the clinical research site (CRS) investigator's opinion. Such conditions may be discussed with the protocol chair/vice chair (actgcorea5277@fstrf.org).
  • Participation in a prior A5277 cohort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Alabama Therapeutics CRS

Birmingham, Alabama, 35294-2050, United States

Location

UCLA CARE Center CRS

Los Angeles, California, 90035, United States

Location

Ucsd, Avrc Crs

San Diego, California, 92103, United States

Location

Ucsf Aids Crs

San Francisco, California, 94110, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Duke Univ. Med. Ctr. Adult CRS

Durham, North Carolina, 27710, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267-0405, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Puerto Rico-AIDS CRS

San Juan, 00935, Puerto Rico

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mark Sulkowski, MD

    Johns Hopkins University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2010

First Posted

July 19, 2010

Study Start

September 1, 2010

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(9)PR(1)