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The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic, biochemical, and histological response will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIntron | Experimental | All participants received PegIntron (Peginterferon alfa-2b) weekly based on their body weight. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b (PegIntron, SCH 54031) | Biological | Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Virological Response | For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT). | 52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation |
| Number of Participants With a Biochemical Response | A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L. | 52 weeks (EOT), 104 weeks (EOF) |
| Number of Participants With a Combined Response | The combined response was defined as an ALT level below the upper reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L. | 52 weeks (EOT), 104 weeks (EOF) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response) | Serum samples collected from the participants were tested by PCR to detect HBV-DNA. HBV response was defined as the absence of HBV-deoxyribonucleic acid (HBV-DNA) in serum. | 52 week (EOT) |
| Number of Participants With a Liver Histology Response |
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Inclusion Criteria:
Exclusion Criteria:
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Of the enrolled participants, 19 received no study medication and 1 was not eligible. The Intent-to-Treat (ITT) population is 48.
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| ID | Title | Description |
|---|---|---|
| FG000 | PegIntron | Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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The liver histology response was defined as at least a 2 point decrease in the necrosis inflammation score (a sum of periportal necrosis [0-10], lobular inflammation [0-4], portal inflammation [0-4], with the total score of 18 representing the worst outcome) and no increase or regression of fibrosis (scored [0-4]) in the pre- and post-treatment liver biopsies. The efficacy of treatment based on histological response was assessed by the investigator as complete response, partial response, minimal response, progressive disease, and not assessable at EOT. |
| Baseline and 52 week (EOT) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PegIntron | Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | ITT Population | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| 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 a Virological Response | For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT). | The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis. | Posted | Number | Participants | 52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation |
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| Secondary | Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response) | Serum samples collected from the participants were tested by PCR to detect HBV-DNA. HBV response was defined as the absence of HBV-deoxyribonucleic acid (HBV-DNA) in serum. | The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis. | Posted | Number | Participants | 52 week (EOT) |
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| Primary | Number of Participants With a Biochemical Response | A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L. | The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis. | Posted | Number | Participants | 52 weeks (EOT), 104 weeks (EOF) |
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| Primary | Number of Participants With a Combined Response | The combined response was defined as an ALT level below the upper reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L. | The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis. | Posted | Number | Participants | 52 weeks (EOT), 104 weeks (EOF) |
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| Secondary | Number of Participants With a Liver Histology Response | The liver histology response was defined as at least a 2 point decrease in the necrosis inflammation score (a sum of periportal necrosis [0-10], lobular inflammation [0-4], portal inflammation [0-4], with the total score of 18 representing the worst outcome) and no increase or regression of fibrosis (scored [0-4]) in the pre- and post-treatment liver biopsies. The efficacy of treatment based on histological response was assessed by the investigator as complete response, partial response, minimal response, progressive disease, and not assessable at EOT. | The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis. | Posted | Number | Participants | Baseline and 52 week (EOT) |
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Adverse events are reported for all 48 participants that received study medication and included the ITT population, as well as one participant that was identified to be ineligible for the study after enrollment.
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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 | PegIntron | Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks | 3 | 49 | 47 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PANCREATITIS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
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| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VERTIGO | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
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| VISION BLURRED | Eye disorders | MedDRA 12.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 12.0 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 12.0 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA 12.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 12.0 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 12.0 | Systematic Assessment |
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| IRRITABILITY | General disorders | MedDRA 12.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
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| ANOREXIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| ANGER | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Late Stage Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019701 | Hepatitis D, Chronic |
| D019694 | Hepatitis B, Chronic |
| D003699 | Hepatitis D |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| 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 |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
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| Title | Measurements |
|---|---|
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| Non-responders at 104 weeks |
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