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The purposes of the PLUS study were to confirm the safety and tolerability of two doses of LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior anti-HCV therapies (Panels A and B), and then to continue to study the safety, tolerability, and preliminary efficacy of the same two doses of LocteronTM (320 ug and 640 ug) in treatment-naïve genotype 1 HCV patients when Locteron dosed over 12 weeks (Panel C). All subjects were also to receive oral daily weight-based ribavirin.
Panels A and B of the PLUS study were designed to assess the safety and tolerability, pharmacokinetics, and viral kinetics over four weeks of two doses of Locteron™ (230 ug and 640 ug) given every two weeks in comparison with PegIntron® given weekly in treatment-experienced subjects with chronic hepatitis C of any genotype who were co-administered weight-based oral ribavirin. The two cohorts of 16 subjects each in Panels A and B consisted of subjects who had failed prior interferon therapy. In Panel A, 8 subjects were randomized to and completed 4 weeks of treatment with 320 μg Locteron™ and 8 subjects were randomized to and completed 4 weeks of treatment with 1.5 ug/kg PegIntron®. In Panel B, 8 subjects were randomized to and completed 4 weeks of treatment with 640 μg Locteron™ and 8 subjects were randomized to and completed 4 weeks of treatment with 1.5 ug/kg PegIntron®. When the results of Panel A and Panel B were known, conduct of Panel C for 12 weeks in treatment-naive patients with chronic genotype-1 HCV was considered unnecessary and cancelled, and an entirely new study was begun instead.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A, C, 320 mcg | Experimental | Bi-weekly subcutaneous doses of Locteron (controlled-release interferon alpha 2b) with oral ribavirin. |
|
| B, C, 640 mcg | Experimental | Bi-weekly subcutaneous doses of Locteron (controlled-release interferon alpha 2b) with oral ribavirin. |
|
| A, B, C PEG | Active Comparator | Weekly subcutaneous injections of 1.5 ug/kg PegIntron (12 kDalton pegylated interferon alpha 2b) with oral ribavirin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Locteron (controlled-release interferon alpha 2b) | Other | biological+device, bi-weekly subcutaneous injections for 4-12 weeks, 160 mcg per injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess in subjects with chronic hepatitis C the safety and tolerability of Locteron in comparison with PEG-Intron. | 7 months (4 weeks of treatment, 6 months of follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess in subjects with chronic hepatitis C receiving a weight-based oral daily dose of ribavirin: • The PK profile of Locteron (IFNa2b) • The preliminary efficacy of Locteron assessed by serial quantitation of HCV RNA levels | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walker Long, MD | Biolex Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States | ||
| Methodist Dallas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Lawitz E, Younossi ZM, Shiffman M, Gordon S, Ghalib R, Long W, Muir A, McHutchison J. Randomized trial comparing systemic and local reactions to controlled-release interferon alpha2b and pegylated-interferon alpha2b in hepatitis C subjects who failed prior treatment. J Hepatology 50:S231 (abstract 628), 2009. (Presented to the 44th Annual Meeting Of The European Association for the Study of the Liver, April 22-26, 2009.) |
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|
| pegylated IFNa2b | Biological | biological, weekly subcutaneous injections for 4-12 weeks, 1.5 mcg/kg |
|
|
| Dallas |
| Texas |
| 75208 |
| United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Inova Center for Liver Diseases | Annandale | Virginia | 22003 | United States |
| McGuire DVAMC, McGuire Research Institute | Richmond | Virginia | 23249 | United States |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D004066 | Digestive System Diseases |
| D018178 | Flaviviridae Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C527994 | locteron |
| C417083 | peginterferon alfa-2b |
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