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Trial information
EAP (Expanded Access Program). A Study of PEGASYS (Peginterferon alfa-2a (40KD))Monotherapy and Combination Therapy With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC).
Status: Completed
Protocol number: BV16209
Sponsor: F Hoffmann-La Roche Ltd./Inc/AG/Roche Global Business
Company division: Pharmaceutical
Official Scientific Title: An expanded-access, open-label study of the safety and tolerability of PEGASYS alone and in combination with ribavirin in patients with chronic hepatitis C.
Brief summary: This Expanded Access Program will assess the safety and tolerability of treatment with PEGASYS alone or in combination with ribavirin in patients with CHC. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
Target sample size is 10900.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Safety: Adverse event rate and profile
Key secondary outcomes: 1. Overall ISR summary score; AEs and ISR leading to discontinuation; SAEs; deaths; patient satisfaction/preference; adherence.
Inclusion criteria: - adult patients >=18 years of age;
- CHC infection;
- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
- use of 2 forms of contraceptive methods during and 6 months after the study in both men and women.
Exclusion criteria: - women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- patients who did not respond to previous interferon or interferon plus ribavirin therapy;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:Argentina Australia Austria Bangladesh Belgium Brazil Bulgaria Canada - Calgary, AB
- Edmonton, AB
- Red Deer, AB
- Abbotsford, BC
- Nelson, BC
- New Westminster, BC
- North Vancouver, BC
- Surrey, BC
- Vancouver, BC
- Vernon, BC
- Victoria, BC
- Winnipeg, MB
- Moncton, NB
- Hunstville
- St John'S
- Halifax, NS
- Barrie, ON
- Brampton, ON
- Downsview, ON
- Etobicoke, ON
- Guelph, ON
- Hamilton, ON
- Kingston, ON
- London, ON
- Mississauga, ON
- Newmarket, ON
- Oshawa, ON
- Ottawa, ON
- Pickering, ON
- Scarborough, ON
- Thornhill, ON
- Thunder Bay, ON
- Toronto, ON
- Vancouver, ON
- Windsor, ON
- Summerside, PE
- Montreal, QC
- Westmount, QC
- Regina, SK
- Saskatoon, SK
Chile China - Beijing
- Changchun
- Changzhou
- Chengdu
- Chongqing
- Fuzhou
- Guangzhou
- Hangzhou
- Harbin
- Hong Kong
- Jinan
- Kunming
- Nanjing
- Ningbo
- Shanghai
- Shenyang
- Shenzhen
- Wuhan
- Xi'An
- Zhengzhou
Colombia Croatia Czech Republic Denmark Egypt Finland Greece Hungary India Indonesia Ireland Israel Italy Kuwait Latvia Lithuania Malaysia Mexico Morocco Netherlands New Zealand Norway Oman Peru Poland Qatar Romania Russian Federation Serbia and Montenegro Slovakia Slovenia Spain - Alcala De Henares
- Alcorcon
- Alicante
- Almería
- Burgos
- Cádiz
- Galdakao
- Girona
- Granada
- La Laguna
- Las Palmas de Gran Canaria
- Leon
- Lleida
- Madrid
- Malaga
- Pamplona
- Reus
- Sabadell
- Sagunto
- Salamanca
- Sevilla
- Tarragona
- Terrassa
- Toledo
- Valencia
- Valladolid
- Vitoria
- Zaragoza
Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom Uruguay Venezuela
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