genotype-3: Efficacy Study of New Therapeutic Schedules in Naive Hepatitis C Virus (HCV) Patients Infected With Genotype 3 (HCV-3)

Sponsor

Casa Sollievo della Sofferenza IRCCS (Other)

Overall Status

Completed

CT.gov ID

NCT01121705

Collaborator

(none)

360

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis	Drug: Peg Interferon alpha2b + Ribavirin	Phase 3

Detailed Description

Patients are randomized to standard length of treatment or to a variable duration: 12 weeks for patients with undetectable HCVRNA at week 4 or 24 or 36 weeks for those with detectable HCV RNA at week 4.

Study Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Multicenter Study on Efficacy of New Therapeutic Schedules With Peg-Interferon alpha2b and Ribavirin in Patients With Genotype 3 Chronic HCV( Hepatitis C Virus) Infection

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: A1. standard duration 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.
Experimental: B 1 I or II 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 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 Other Names: variable

Arm

Intervention/Treatment

No Intervention: A1. standard duration

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.

Experimental: B 1 I or II

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

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

Other Names:

variable

Outcome Measures

Primary Outcome Measures

Sustained virological response (SVR) [6 months after the end of treatment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	Country
1	Ospedale Civile	Canossa	Italy
2	Ospedale Casarano	Casarano	Italy
3	IRCCS "De Bellis"	Castellana Grotte	Italy
4	Ospedale "Garibaldi"	Catania	Italy
5	Ospedale "S.Camillo"	Rome	Italy
6	Università Cattolica Sacro Cuore Roma	Rome	Italy
7	Ospedale Civile	Sassari	Italy
8	Ospedale Venosa	Venosa	Italy