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This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). Anticipated time on study treatment is 2+ years, target sample size is <50.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a [Pegasys] | Drug | 180mcg sc weekly, 96 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients becoming HDV-RNA negative | week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology | weeks 48, 96 and after 24 weeks of follow-up | |
| Safety and tolerability: adverse events, laboratory parameters, vital signs | throughout 96 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University Medical Facility; Hepatology Department | Ankara | 06620 | Turkey (Türkiye) | |||
| Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30833068 | Derived | Wedemeyer H, Yurdaydin C, Hardtke S, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Keskin O, Port K, Radu M, Celen MK, Idilman R, Weber K, Stift J, Wittkop U, Heidrich B, Mederacke I, von der Leyen H, Dienes HP, Cornberg M, Koch A, Manns MP; HIDIT-II study team. Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial. Lancet Infect Dis. 2019 Mar;19(3):275-286. doi: 10.1016/S1473-3099(18)30663-7. |
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| placebo |
| Drug |
orally daily, 96 weeks |
|
| tenofovir | Drug | 245mg po daily, 96 weeks |
|
| Bursa |
| 16059 |
| Turkey (Türkiye) |
| Dicle Uni Medical Faculty; Gastroenterology | Diyarbakır | 10000 | Turkey (Türkiye) |
| Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy | Istanbul | 34390 | Turkey (Türkiye) |
| Ege Uni Medical Faculty Izmir; Gastroenterology | Izmir | 35100 | Turkey (Türkiye) |
| Dokuz Eylul University Medical Faculty; Infection | Izmir | 35340 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D019701 | Hepatitis D, Chronic |
| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | 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 |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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