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This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target sample size is 48 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Moderate Renal Impairment | Experimental | Participants with CrCl 30 to 50 mL/min will receive 12 weeks of peginterferon alfa-2a, 180 micrograms (mcg) via subcutaneous (SC) injection once weekly, in combination with ribavirin, 600 milligrams (mg) orally (PO) daily in two divided doses. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks. |
|
| Group B: Severe Renal Impairment | Experimental | Participants with CrCl <30 mL/min will receive 12 weeks of peginterferon alfa-2a, 180 mcg via SC injection once weekly, in combination with ribavirin, 400 mg PO daily in two divided doses. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks. |
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| Group C: Hemodialysis/ESRD | Experimental | Participants requiring hemodialysis will receive 12 weeks of peginterferon alfa-2a, 135 mcg via SC injection once weekly, in combination with ribavirin, 200 mg PO every morning. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks. |
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| Group D: Normal Renal Function | Experimental | Participants with CrCl >80 mL/min will receive 12 weeks of peginterferon alfa-2a, 180 mcg via SC injection once weekly, in combination with ribavirin, 800 to 1200 mg PO daily in two divided doses. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | Peginterferon alfa-2a will be administered for 12 to 48 weeks. The dose will range from 135 mcg (Group C) to 180 mcg (Groups A, B, and D) once weekly via SC route. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of peginterferon alfa-2a | Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 | |
| CL/F of ribavirin | Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 | |
| Percentage of participants with undetectable HCV RNA level | Week 12 | |
| Cmax of ribavirin | Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 | |
| AUC of ribavirin | Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 | |
| AUC of peginterferon alfa-2a | Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 | |
| Clearance (CL/F) of peginterferon alfa-2a | Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum concentration (Tmax) of peginterferon alfa-2a | Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 | |
| Tmax of ribavirin | Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
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| Ribavirin | Drug | Ribavirin will be administered for 12 to 48 weeks. The total daily dosage will range from 200 mg (Group C) to 1200 mg (Group D), depending upon CrCl and participant-specific factors. |
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| Plasma concentration of ribavirin | Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 |
| Percentage of participants with adverse events (AEs) | From Baseline to Week 12 (or up to Week 48 if treatment continued) |
| Percentage of participants with a dose modification or premature withdrawal for safety reasons | From Baseline to Week 12 (or up to Week 48 if treatment continued) |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| New Orleans | Louisiana | 70112 | United States |
| Kansas City | Missouri | 64128 | United States |
| St Louis | Missouri | 63110 | United States |
| New York | New York | 10029 | United States |
| Syracuse | New York | 13210 | United States |
| Cleveland | Ohio | 44106 | United States |
| Portland | Oregon | 97239 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Dallas | Texas | 75203 | United States |
| Galveston | Texas | 77555 | United States |
| São Paulo | 04038-002 | Brazil |
| Marseille | 13285 | France |
| Christchurch | 8011 | New Zealand |
| Riccarton, Christchurch | 8011 | New Zealand |
| Huddinge | 14186 | Sweden |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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