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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012924-10 | EudraCT Number |
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The general aim of this study is to determine if 3 MIU of IFN-α5 in monotherapy, and 1,5 MIU of IFN-α5 combined with 1,5 MIU of IFN- α2b, are safe dose levels as well as to investigate the antiviral efficacy and pharmacodynamics (PD) of such doses and drugs in treatment-experienced HCV patients with genotype 1 chronic infection, after 29 days of treatment. It is also intended to determine pharmacokinetics (PK) of the safe dose achieved of IFN-α5 in monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interferon α-5 | Experimental |
| |
| Interferon α-5 plus Interferon α-2b | Experimental |
| |
| Interferon α-2b (INTRON® A) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon α-5 | Drug | 3 MIU or safe dose used three times a week (TIW) in alternate days in monotherapy. 29 days of treatment. Subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safe dose level | PRIMARY ENDPOINTS OF PHASE I
PRIMARY ENDPOINTS OF PHASE II
| 29 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacodynamic and pharmacokinetic parameters | SECONDARY ENDPOINTS OF PHASE I
SECONDARY ENDPOINTS OF PHASE II
|
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Inclusion Criteria:
Exclusion Criteria(principal):
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| Name | Affiliation | Role |
|---|---|---|
| Jesús Prieto, MD, PhD | Clínica Universidad de Navarra. Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre 013 | A Coruña | Spain | ||||
| Centre 004 |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 23, 2014 | |
| Reset | May 21, 2014 |
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| Interferon-α5 plus Interferon-α 2b | Drug | 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. |
|
| Interferon α-2b (INTRON® A) | Drug | 3 million IU TIW in alternate days in monotherapy. 29 days of treatment. Subcutaneous injection. |
|
| 29 days of treatment |
| Barcelona |
| Spain |
| Centre 005 | Barcelona | Spain |
| Centre 008 | Barcelona | Spain |
| Centre 011 | Barcelona | Spain |
| Centre 014 | Granada | Spain |
| Centre 015 | León | Spain |
| Centre 002 | Madrid | Spain |
| Centre 003 | Madrid | Spain |
| Centre 006 | Madrid | Spain |
| Centre 009 | Madrid | Spain |
| Centre 016 | Madrid | Spain |
| Centre 001 | Pamplona | Spain |
| Centre 012 | Santander | Spain |
| Centre 010 | Seville | Spain |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 23, 2014 | May 21, 2014 |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007438 | Introns |
| ID | Term |
|---|---|
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
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