- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00249860
A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
A Multicentre Phase III Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or combination therapy.
This will be a multicenter, randomized, double-blind, placebo-controlled study with a placebo to be crossed-over to a combination of interferon-beta-1a and ribavirin or no treatment during an open-label extension phase. The duration of the trial will be 48 weeks, with a double-blind period of 12 weeks.
The study will recruit 257 eligible subjects of either sex. It will be conducted by approximately 16 Investigators / investigational centers in 3 countries (China, Hong Kong and Singapore).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age between 18 and 65 years
- Have an elevated serum alanine aminotransferase (ALT) between 1.5 and 10 times the upper limit of normal
- Had adequate bone marrow reserve and organ function
- Are not pregnant and are willing to use contraception, if, of childbearing potential
- Are willing and able to comply with the protocol and to give written informed consent
- Other protocol defined inclusion criteria may apply
Exclusion Criteria:
- Clinical evidence of liver cirrhosis or a diagnosis of definite cirrhosis on liver biopsy
- History of liver failure, severe retinopathy, immunologically mediated disease, cancer or epilepsy with a history of inadequately controlled seizures
- Any cause for the liver disease other than chronic hepatitis C
- Evidence of chronic renal impairment, liver cancer, unstable psychiatric disorder, known or ongoing alcohol or drug abuse
- Positive test at screening for Hepatitis B surface antigen, immunoglobulin M Hepatitis B core antibody and human immunodeficiency virus antibody
- Previous systemic treatment for Hepatitis C with an interferon or ribavirin
- Presence of systemic disease that might interfere with subject safety, compliance or evaluation
- Known allergies to acetaminophen, human serum albumin or mannitol;
- Glucocorticosteroids or other immunosuppressive drugs taken within 28 days of starting treatment
- Bearing organ transplants (except cornea)
- Other protocol defined exclusion criteria may apply
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Interferon-beta-1a
|
Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24
|
Aktiv komparator: Ribavarin plus interferon-beta-1a
|
Matching placebo will be administered subcutaneously three times a week for 12 weeks.
The placebo responders will continue the study off-treatment after Week 12 up to Week 24
Placebo non-responders at Week 12 will receive ribavirin at a dose of 1000 milligram (mg) or 1200 mg orally once daily in combination with Interferon-beta-1a, administered subcutaneously at a dose of 44 mcg three times a week, from Week 16 up to Week 24
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percentage of subjects achieving sustained viral response (SVR) at Week 24
Tidsramme: Week 24
|
Week 24
|
Percentage of subjects achieving sustained viral response (SVR) at Week 48
Tidsramme: Week 48
|
Week 48
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from baseline in viral load (Hepatitis C virus ribonucleic acid [HCV RNA]) at Week 12, 24, and 48
Tidsramme: Baseline, Week 12, 24, and 48
|
Baseline, Week 12, 24, and 48
|
Percentage of subjects with Alanine transaminase (ALT) normalization
Tidsramme: Week 12, 24, and 48
|
Week 12, 24, and 48
|
Percentage of subjects with viral clearance
Tidsramme: Week 12 and 24
|
Week 12 and 24
|
Percentage of subjects with both SVR and sustained ALT normalization
Tidsramme: Week 48
|
Week 48
|
Number of subjects with improvement in the liver necroinflammation score by at least two points
Tidsramme: Week 48
|
Week 48
|
Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point
Tidsramme: Week 48
|
Week 48
|
Number of subjects with adverse events and serious adverse events
Tidsramme: Baseline up to Week 48
|
Baseline up to Week 48
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Theodor Wee, M.D., Serono Singapore Ltd, an affiliate of Merck Serono SA, Singapore
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Leversygdomme
- Flaviviridae infektioner
- Hepatitis, viral, menneskelig
- Enterovirus infektioner
- Picornaviridae infektioner
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, kronisk
- Hepatitis C, kronisk
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Antimetabolitter
- Antineoplastiske midler
- Immunologiske faktorer
- Adjuvanser, immunologiske
- Interferoner
- Interferon beta-1a
- Ribavirin
- Interferon-beta
Andre undersøgelses-id-numre
- 23744
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