Different Ribavirin Dosages and Different Duration of Treatment in Combination With PegInterferon in Patients With Genotype 2 and 3 (WRITE)
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Purpose
WRITE study aim at identifying the effectiveness of an innovative individualized schedule of treatment as compared to standard regimen in patients with chronic HCV genotype 2 and 3.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis |
Drug: Peginterferon alpha-2a + Ribavirin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | RCT Comparing Different Ribavirin Dosages and Durations of Treatment in Combination With Peginterferon in HCV Genotypes 2 and 3 (WRITE) |
- Sustained virological Response (SVR) [ Time Frame: 6 months after the end of treatment ] [ Designated as safety issue: No ]The primary measure of efficacy will be HCV RNA not detectable in serum samples 24 weeks after the end of therapy (SVR).
- Rapid virological response (RVR) [ Time Frame: On treatment week 4 ] [ Designated as safety issue: No ]proportion of patients with undetectable HCV RNA 4 weeks after the start of treatment
| Estimated Enrollment: | 1150 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Arm C. Standard duration
Patients will be randomly assigned in 3:3:1 ratio to three treatment arms. In the standard treatment group (Arm C), patients will be treated for 24 weeks independently of the HCV RNA status at week 4 with Peginterferon alpha-2a at a dose of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 800 mg/day. Patients enrolled in Arm C will be treated for standard 24 weeks duration of treatment. |
|
|
Experimental: Arm A
Patients enrolled in Arm A will receive Peginterferon alpha-2a at a dosage of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 1000 mg/day for patients with a body weight < 75 kg or 1200 mg/day for those with a body weight > 75 kg. Patients with week 4 viral clearance (labelled as rapid virological responders, RVR) will be allocated to 12 week treatment duration (Arm A), whereas those without RVR will be treated for 24 weeks (Arm A) |
Drug: Peginterferon alpha-2a + Ribavirin
Administration of ribavirin at a dosage of 1000 or 1200 mg per day based on body weight < or > 75 kg for 24 weeks (Arm A). Treatment duration of 48 weeks with standard fixed dose of ribavirin (800 mg/day) (Arm B). These schedules will be compared with diagram of standard therapy with 800 mg daily of ribavirin for 24 weeks (Arm C) Other Names:
|
|
Experimental: Arm B
Patients enrolled in Arm B will receive Peginterferon alpha-2a at a dosage of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 800 mg/day. Patients with week 4 viral clearance (labelled as rapid virological responders, RVR) will be allocated to 12 week treatment duration (Arm B), whereas those without RVR will be treated for 48 weeks (Arm B) |
Drug: Peginterferon alpha-2a + Ribavirin
Administration of ribavirin at a dosage of 1000 or 1200 mg per day based on body weight < or > 75 kg for 24 weeks (Arm A). Treatment duration of 48 weeks with standard fixed dose of ribavirin (800 mg/day) (Arm B). These schedules will be compared with diagram of standard therapy with 800 mg daily of ribavirin for 24 weeks (Arm C) Other Names:
|
Detailed Description:
The investigators are going to compare weight-based dosages of ribavirin, in combination with Peginterferon alpha-2a, with standard fixed dosages of 800 mg. Patients will be evaluated at week 4 with an assay of sensitivity of 15 IU/ml. Patients with week 4 response will discontinue treatment at week 12 in both arms. Patients with HCV RNA still detectable at week 4 and receiving 1000-1200 mg of ribavirin in arm A will discontinue treatment at week 24, whereas patients with HCV RNA still detectable at week 4 and receiving 800 mg of ribavirin in arm B will be treated till week 48.
A standard treatment arm (C) including patients treated for 24 weeks with Peginterferon alpha-2a and fixed 800 mg ribavirin dosage will be used as control arm.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with chronic hepatitis C virus (HCV) infection (both HCVAb and HCV RNA positive)
- Patients with HCV genotype 2 or 3
- Age 18-70 years
- Naïve patients or previously treated only with standard interferon monotherapy
- Female patients of childbearing age who agree to avoid pregnancy during the period of treatment and 24 weeks after the end of treatment
Exclusion Criteria:
- Previous treatment with ribavirin
- Cirrhosis (CHILD PUGH B and C)
- Evidence of Hepatocellular carcinoma
- Pregnancy
- Retinopathy class I or II
- Alcohol consumption > 40 gr/day
- Chronic cardiac or respiratory diseases
- HIV or HBsAg or HDV positivity
- Hemoglobin < 8.5 gr/dL
- WBC < 3.500/mm3
- PLT < 80.000/mm3
Contacts and Locations| Contact: Alessandra Mangia, MD | +39-0882-416270 | a.mangia@operapadrepio.it |
| Italy | |
| Infectious Diseases Unit | Recruiting |
| Avellino, Italy | |
| Contact: Patrizia Maio, MD | |
| Infectious Diseases Unit | Recruiting |
| Avellino, Italy | |
| Contact: Salvatore D'Angelo | |
| Clinical Medicine Unit "Mater Dei" | Recruiting |
| Bari, Italy | |
| Contact: Ernesto Agostinacchio, MD | |
| Università di Bari | Recruiting |
| Bari, Italy | |
| Contact: Franco Dammacco, MD | |
| Medicine Unit | Recruiting |
| Barletta, Italy | |
| Contact: Giuseppe Cuccorese, MD | |
| Infectious Diseases Unit "V. Emanuele" | Recruiting |
| Bisceglie, Italy | |
| Contact: Ruggiero Francavilla, MD | |
| Medicine Unit | Recruiting |
| Canosa di Puglia, Italy | |
| Contact: Nicola Minerva, MD | |
| Hepatology Unit | Recruiting |
| Casarano, Italy | |
| Contact: Donato Bacca, MD | |
| IRCCS "De Bellis" | Recruiting |
| Castellana, Italy | |
| Contact: Raffaele Cozzolongo, MD | |
| Hepatology Unit | Recruiting |
| Catania, Italy | |
| Contact: Maurizio Russello, MD | |
| Infectious Diseases Unit | Recruiting |
| Catania, Italy | |
| Contact: Luciano Nigro, MD | |
| Gastroenterology Unit | Recruiting |
| Como, Italy | |
| Contact: Giancarlo Spinzi, MD | |
| Gastroenterology Unit Arcispedale "S. Anna" | Recruiting |
| Ferrara, Italy | |
| Contact: Boccia Sergio, MD | |
| Internal Medicine University of Firenze | Recruiting |
| Firenze, Italy | |
| Contact: Anna L Zignego, MD | |
| Gastroenterology Unit | Recruiting |
| Firenze, Italy | |
| Contact: Paolo Forte, MD | |
| Infectious Diseases | Recruiting |
| Foggia, Italy | |
| Contact: Gaetano Scotto, MD | |
| Gastroenterology Unit | Recruiting |
| Foggia, Italy | |
| Contact: Francesco Vinelli, MD | |
| Gastroenterology Unit | Recruiting |
| Galatina, Italy | |
| Contact: Paolo Tundo, MD | |
| Infectious Diseases | Recruiting |
| Lucca, Italy | |
| Contact: Sauro Luchi, MD | |
| Gastroenterology Unit | Recruiting |
| Mottola, Italy | |
| Contact: Antonio Termite, MD | |
| Gastroenterology Unit "Cardarelli" | Recruiting |
| Napoli, Italy | |
| Contact: Giovanni Di Costanzo, MD | |
| USL Napoli 1 | Recruiting |
| Napoli, Italy | |
| Contact: Mario Colucci, MD | |
| Hospital "V. Cervello" | Recruiting |
| Palermo, Italy | |
| Contact: Salvo Madonia, MD | |
| Medical Clinic University of Palermo | Recruiting |
| Palermo, Italy | |
| Contact: Giuseppe Montalto, MD | |
| Infectious Diseases Unit IRCCS "San Matteo" | Recruiting |
| Pavia, Italy | |
| Contact: Giorgio Barbarini, MD | |
| Hepatology Unit "san Camillo" | Recruiting |
| Roma, Italy | |
| Contact: Adriano Pellicelli, MD | |
| Campus Biomedico University | Recruiting |
| Roma, Italy | |
| Contact: Antonio Picardi, MD | |
| Hepatology Unit "S. Pertini" | Recruiting |
| Roma, Italy | |
| Contact: Mario Romano, MD | |
| Ospedale "Villa Betania" | Recruiting |
| Roma, Italy | |
| Contact: Mecenate Fabrizio, MD | |
| IRCCS "L. Spallanzani" | Recruiting |
| Rome, Italy | |
| Contact: Pasquale Narciso, MD | |
| IRCCS "Casa Sollievo della Sofferenza" | Recruiting |
| San Giovanni Rotondo, Italy, 71013 | |
| Contact: Alessandra Mangia, MD +39-0882-416270 a.mangia@operapadrepio.it | |
| Contact: Leonardo Mottola, PhD +39-0882-416271 leonardomottola@yahoo.it | |
| Infectious Diseases Unit Ospedale Civile | Recruiting |
| Sassari, Italy | |
| Contact: Sergio Baudieri, MD | |
| Medicine Unit | Recruiting |
| Sassari, Italy | |
| Contact: Franco Bandiera, MD | |
| Infectious Diseases | Recruiting |
| Siracusa, Italy | |
| Contact: Gaetano Scifo, MD | |
| SS. Annunziata | Recruiting |
| Taranto, Italy | |
| Contact: Fernando Sogari, MD | |
| Medicine Unit | Recruiting |
| Venosa, Italy | |
| Contact: Vito Carretta, MD | |
| Study Director: | Alessandra Mangia, MD | IRCCS "Casa Sollievo della Sofferenza" |
More Information
Publications:
| Responsible Party: | Alessandra Mangia, MD, Casa Sollievo della Sofferenza IRCCS |
| ClinicalTrials.gov Identifier: | NCT01380938 History of Changes |
| Other Study ID Numbers: | EPAT-01-2010 |
| Study First Received: | June 23, 2011 |
| Last Updated: | April 14, 2012 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Casa Sollievo della Sofferenza IRCCS:
|
genotypes 2 and 3 combination treatment individualized treatment |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Ribavirin |
Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013