NCT01121705

Brief Summary

The study aimed at evaluating whether current 24 weeks length of combination treatment is appropriate or not for patients with HCV genotype 3 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

8 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

January 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
Last Updated

August 10, 2011

Status Verified

June 1, 2009

Enrollment Period

2.4 years

First QC Date

May 4, 2010

Last Update Submit

August 9, 2011

Conditions

Chronic Hepatitis

Keywords

genotype 3Combination treatmentShort treatment

Outcome Measures

Primary Outcomes (1)

  • Sustained virological response (SVR)

    The primary measure of efficacy will be HCV RNA not detectable in the serum 24 weeks after the end of therapy (SVR). In addition, virological response at the end of treatment and relapse rates will be calculated for each groups. Two analyses will be performed: 1) intention-to-treat analysis; 2) per-protocol analysis.

    6 months after the end of treatment

Study Arms (2)

A1. standard duration

NO INTERVENTION

Patients were randomly assigned in a 1:1 ratio to two treatment arms. In the standard treatment group (A1), patients were treated for 24 weeks irrespective of the HCV RNA status at week 4 with Peg-interferon alfa-2b at a dose of 1.5 mcg per kilogram of body weight weekly in combination with oral ribavirin administered at a dose of 1000 mg/day for patients with a weight \<75 kg or 1200 mg/day for those with a weight of ≥75 kg. Patients enrolled in Arm A1 will be treated for standard 24 weeks duration of treatment with standard dosages of PegInterferon alpha 2b and weight-based dosages of ribavirin.

B 1 I or II

EXPERIMENTAL

In the variable treatment group, patients with a virologic response at week 4 will receive treatment for 12 weeks and those without a virologic response at 4 weeks treatment for 36 weeks. Patients without RVR will be treated for 24 or 36 weeks and labelled (B1I) or (B1II, respectively Intervention: different durations of treatment for patients without RVR

Drug: Peg Interferon alpha2b + Ribavirin

Interventions

Peg Interferon alpha2b + RibavirinDRUG

B 1 I or II: Experimental variable duration of treatment group according with RVR. In case of RVR present patients will be treated for 12 weeks. Patients without RVR will be treated for 24 (B1I) or 36 (B1II)weeks: different duration of treatment for patients without RVR

Also known as: variable
B 1 I or II

Eligibility Criteria

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

You may qualify if:

  • Naive HCV patients
  • HCVRNA positive
  • Normal TSH
  • ANA \<1:160

You may not qualify if:

  • Portal hypertension
  • Renal failure
  • HBsAg or HIV
  • Alcohol consumption \>30 g/day
  • Active IV drug use
  • Chronic systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ospedale Civile

Sassari, Sassari, Italy

Location

Ospedale Civile

Canossa, Italy

Location

Ospedale Casarano

Casarano, Italy

Location

IRCCS "De Bellis"

Castellana Grotte, Italy

Location

Ospedale "Garibaldi"

Catania, Italy

Location

Ospedale "S.Camillo"

Rome, Italy

Location

Università Cattolica Sacro Cuore Roma

Rome, Italy

Location

Ospedale Venosa

Venosa, Italy

Location

Related Publications (1)

  • Andriulli A, Mangia A, Iacobellis A, Ippolito A, Leandro G, Zeuzem S. Meta-analysis: the outcome of anti-viral therapy in HCV genotype 2 and genotype 3 infected patients with chronic hepatitis. Aliment Pharmacol Ther. 2008 Aug 15;28(4):397-404. doi: 10.1111/j.1365-2036.2008.03763.x. Epub 2008 Jun 11.

    PMID: 18549461BACKGROUND

MeSH Terms

Conditions

Hepatitis, Chronic

Interventions

peginterferon alfa-2bRibavirin

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Alessandra Mangia, MD

    IRCCS - San Giovanni Rotondo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 12, 2010

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

August 10, 2011

Record last verified: 2009-06

Locations

IT(8)