NCT00953589

Brief Summary

The purpose of this 12-week study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the early virologic response to the 480 ug dose level of Locteron™, dosed every 2 weeks, in comparison with 1.5 ug/kg PEG-Intron™ dosed weekly.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2

Geographic Reach
3 countries

15 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

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 2, 2012

Status Verified

February 1, 2012

Enrollment Period

10 months

First QC Date

August 5, 2009

Last Update Submit

February 1, 2012

Conditions

Hepatitis C, Chronic

Keywords

treatment naive

Outcome Measures

Primary Outcomes (1)

  • Primary efficacy endpoint: EVR: the proportion of subjects in each arm that have at least a 2 log drop in HCV RNA from Baseline

    Week 12

Secondary Outcomes (1)

  • the proportion of subjects in each arm demonstrating HCV RNA undetectable (< 10 IU/mL) after 12 weeks of randomized treatment

    Week 12

Study Arms (4)

Locteron ® PANEL A

EXPERIMENTAL

PANEL A: Locteron™ 480 µg dosed every 2 weeks in two subcutaneous injections (160 µg and 320 µg)

Drug: ribavirin

Locteron ® PANEL B

EXPERIMENTAL

PANEL B: Locteron™ 480 µg dosed every two weeks in single subcutaneous injections

Drug: ribavirin

PEG-Intron® PANEL A

ACTIVE COMPARATOR

PEG-Intron® 1.5 µg/kg body weight weekly subcutaneous injection

Drug: ribavirin

PEG-Intron® PANEL B

ACTIVE COMPARATOR

PEG-Intron® 1.5 µg/kg body weight weekly subcutaneous injection

Drug: ribavirin

Interventions

ribavirinDRUG

Ribavirin - oral administration Subjects with body weight \< 65 kg: 800 mg/day Subjects with body weight 65-85 kg: 1000 mg/day Subjects with body weight 86-105 kg: 1200 mg/day Subjects with body weight \> 105 kg: 1400 mg/day

Also known as: Ribasphere
Locteron ® PANEL ALocteron ® PANEL BPEG-Intron® PANEL APEG-Intron® PANEL B

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects 18 through 69 years of age, inclusive
  • Chronic hepatitis C genotype 1
  • HCV ribonucleic acid (RNA) level \> 10,000 IU/mL (by RT-PCR) at screening
  • Creatine clearance ≥ 50 mL/min
  • Neutrophil count \> 1500 cells/mm3
  • Platelet count \> 90,000/mm3
  • Hemoglobin \> 12 g/dL for females and \> 13 g/dL for males
  • Female subjects of child-bearing potential agreeing to use dual methods for contraception
  • Male subjects with female sexual partners agreeing to use effective birth control methods
  • Negative serum pregnancy test for women of child-bearing potential
  • Compensated liver disease defined as INR \< 1.5, conjugated bilirubin \< 1.5 x ULN, serum albumin \> 3.0 g/dL
  • Histologic evidence of Chronic Hepatitis C (CHC) (inflammation, fibrosis and/or cirrhosis on a standardized histologic grading system) as shown by biopsy within 2 years of screening or agrees to have a liver biopsy performed prior to randomization.

You may not qualify if:

  • Prior antiviral treatment for hepatitis C
  • Co-infection with HIV or hepatitis B virus
  • Subjects with a body mass index (BMI) above 32 kg/m2
  • Current or prior history of clinical hepatic decompensation
  • Evidence of HCC
  • Uncontrolled diabetes mellitus as evidenced by HbA1C ≥ 8.5% at screening
  • Known hypersensitivity to interferon alfa or ribavirin
  • Chronic liver disease other than HCV
  • Clinically significant hemoglobinopathy
  • History of moderate, severe or uncontrolled psychiatric disease including depression and prior suicide attempts
  • History of immune-mediated disease
  • Significant renal or neurological disease
  • Severe degree (\> GOLD stage III) of chronic pulmonary disease (COPD) or active, severe asthma
  • Subjects with severe cardiac disease
  • History of significant central nervous system (including CNS trauma) or seizure disorders
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Tokuda Hospital

Sofia, 1407, Bulgaria

Location

UMHAT "Alexandrovska"

Sofia, 1431, Bulgaria

Location

UMHAT "St Ivan Rilski"

Sofia, 1431, Bulgaria

Location

UMHAT "Queen Giovanna - ISUL" EAD

Sofia, 1527, Bulgaria

Location

Medical Institute Ministry of Interior

Sofia, 1606, Bulgaria

Location

UMHAT "St Maria"

Varna, 9010, Bulgaria

Location

Carmel Medical Center

Haifa, 34341, Israel

Location

Holy Family Hospital Nazareth

Nazareth, 16100, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Rebekah Ziv Medical Center Safed

Safed, 13100, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Institute of Infectious Diseases

Bucharest, 021105, Romania

Location

Fundeni Clinical Institute

Bucharest, 022328, Romania

Location

"Victor Babes" Clinical Hospital Craiova

Craiova, 200515, Romania

Location

Gastroenterology and Hepatology Institute

Iași, 700111, Romania

Location

Related Publications (1)

  • Krastev Z, Kotzev I, Tchernev K, Rigney A, Nikolovska D, Vladimirov B, Caruntu FA, Diaconescu IG, Voiculescu XX, Long, WA. Randomized, open-label, 12-week comparison of controlled-release interferon alpha2b + ribavirin vs. pegylated interferon alpha 2b +ribavirin in treatment-naïve genotype1 hepatitis C: 4 week results from 480STUDY (Panel A). J Hepatology 52:S27 (abstract 58), 2010. (Presented to 45th Annual Meeting of the European Association for the Study of the Liver, April 16, 2010, Vienna, Austria.)

    BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin

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

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Walker A. Long, MD

    Biolex Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

July 1, 2009

Primary Completion

May 1, 2010

Study Completion

January 1, 2011

Last Updated

February 2, 2012

Record last verified: 2012-02

Locations

IL(5)RO(4)BU(6)