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This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Monotherapy with Peginterferon alfa-2a | Experimental | Participants will receive peginterferon alfa-2a alone, administered over 48 weeks. |
|
| Group B: Combination with Peginterferon alfa-2a + Ribavirin | Experimental | Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment | Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported. | Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment | Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported. | Week 48 |
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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 |
|---|---|---|---|---|---|---|
| Cagliari | 09042 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Monotherapy With Peginterferon Alfa-2a | Participants received peginterferon alfa-2a for 48 weeks as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection. |
| FG001 | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 milligrams (mg) per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intent-to-Treat (ITT) Population: All participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Monotherapy With Peginterferon Alfa-2a | Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection. |
| BG001 | Group B: Combination With Peginterferon Alfa-2a + Ribavirin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment | Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported. | ITT Population. | Posted | Number | participants | Week 96 |
|
Baseline through 24 weeks after end of treatment (up to 72 weeks)
Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Monotherapy With Peginterferon Alfa-2a | Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D019701 | Hepatitis D, Chronic |
| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
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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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|
| Ribavirin | Drug | Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses. |
|
|
| Number of Participants With ALT Normalization at 48 Weeks After End of Treatment | Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported. | Week 96 |
| Number of Participants With ALT Normalization at End of Treatment | Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported. | Week 48 |
| Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment | Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported. | Week 96 |
| Number of Participants With Negative HDV RNA at End of Treatment | Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported. | Week 48 |
Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Group B: Combination With Peginterferon Alfa-2a + Ribavirin |
Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline. |
|
|
|
| Secondary | Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment | Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported. | ITT Population. | Posted | Number | participants | Week 48 |
|
|
|
| Secondary | Number of Participants With ALT Normalization at 48 Weeks After End of Treatment | Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported. | ITT Population. | Posted | Number | participants | Week 96 |
|
|
|
|
| Secondary | Number of Participants With ALT Normalization at End of Treatment | Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported. | ITT Population. | Posted | Number | participants | Week 48 |
|
|
|
|
| Secondary | Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment | Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported. | ITT Population. | Posted | Number | participants | Week 96 |
|
|
|
|
| Secondary | Number of Participants With Negative HDV RNA at End of Treatment | Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported. | ITT Population. | Posted | Number | participants | Week 48 |
|
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|
|
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline. | 0 | 6 | 6 | 6 |
| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Emotional disorder | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| 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 |