A Phase I/II Clinical Trial With Interferon Alfa 5 in Treatment-Experienced Patients With Genotype-1 Chronic Hepatitis C
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|ClinicalTrials.gov Identifier: NCT01121731|
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : February 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Virus Infection Genotype 1 Treatment-Experienced Patients Relapses||Drug: Interferon α-5 Drug: Interferon-α5 plus Interferon-α 2b Drug: Interferon α-2b (INTRON® A)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II, Multicenter, Randomized, Open,Active-Controlled, ClinicalTrial to Evaluate PK, PD, Safety and Tolerability Of Interferon Alfa 5, S.C. 3 Times Per Week, For 29 Days, To Treat-Experienced Pat. With Genotype-1 Chronic Hepatitis C|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||January 2013|
|Experimental: Interferon α-5||
Drug: Interferon α-5
3 MIU or safe dose used three times a week (TIW) in alternate days in monotherapy. 29 days of treatment. Subcutaneous injection.
|Experimental: Interferon α-5 plus Interferon α-2b||
Drug: Interferon-α5 plus Interferon-α 2b
Interferon-α5 plus Interferon-α 2b. 1.5 MIU each, or safe dose used TIW in alternate days in combined therapy. 29 days of treatment. Subcutaneous injection.
|Active Comparator: Interferon α-2b (INTRON® A)||
Drug: Interferon α-2b (INTRON® A)
3 million IU TIW in alternate days in monotherapy. 29 days of treatment. Subcutaneous injection.
- Safe dose level [ Time Frame: 29 days of treatment ]
PRIMARY ENDPOINTS OF PHASE I
- To determine if 3 MIU of IFN-α5 are well tolerated and if not, to find a safe dose level for IFN-α5.
- To determine if 1.5 MIU of IFN-α5 in combination with 1.5 MIU of IFN-α2b (IFN-α5 + IFN-α2b) are well tolerated and if not, to find a safe dose level for the combination of IFN-α5 and IFN-α2b.
PRIMARY ENDPOINTS OF PHASE II
- To analyze IFN-α5 preliminary antiviral efficacy at the dose of 3 MIU, or the safe dose level identified in Phase I.
- Primary safety endpoints: Occurrence of AE (classified into mild, moderate and severe)
- pharmacodynamic and pharmacokinetic parameters [ Time Frame: 29 days of treatment ]
SECONDARY ENDPOINTS OF PHASE I
- To obtain pharmacokinetic parameters of IFN-α5 in monotherapy after single and multiple dose administration
- To obtain pharmacodynamic parameters of IFN-α5 in monotherapy and in combination with IFN-α2b
SECONDARY ENDPOINTS OF PHASE II
- To analyze IFN-α5 + IFN-α2b preliminary antiviral efficacy and comparison between IFN-α5 in monotherapy, IFN-α5 + IFN-α2b and IFN-α2b in monotherapy.
- To obtain pharmacodynamic parameters after treatment with IFN-α5, IFN-α5 + IFN-α2b or IFN-α2b.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121731
|A Coruña, Spain|
|Principal Investigator:||Jesús Prieto, MD, PhD||Clínica Universidad de Navarra. Spain|