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This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegylated Interferon (PEG-IFN) alfa-2a | Experimental | Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Interferon (PEG-IFN) alfa-2a | Drug | Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 | Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay. | At Week 72 |
| Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72 | Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay. | At Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Normal ALT at Week 48 | Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay. | At Week 48 |
| Percentage of Participants With Negative HDV RNA at 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 |
|---|---|---|---|---|---|---|
| Bucharest | 021105 | Romania | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegylated Interferon (PEG-IFN) Alfa-2a | Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up. Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegylated Interferon (PEG-IFN) Alfa-2a | Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up. Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks. |
| 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 | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 | Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay. | Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 72 |
|
Up to week 72
The following adverse events (AEs) were recorded in this study: flu-like symptoms, myalgia, asthenia, headache, weight loss, skin rash, hyperthyroidism, conjunctivitis, neutropenia and thrombocytopenia. Neutropenia and thrombocytopenia were the most frequent AEs. Data to assign numbers to these events are not accessible and therefore not reported.
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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 | Pegylated Interferon (PEG-IFN) Alfa-2a | Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up. Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks. |
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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 |
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|
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
| At Week 48 |
| Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72 | Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1*10^5 copies/mL. | At Weeks 48 and 72 |
| Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels | Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay. | At Screening and at Weeks 48 and 72 |
| Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72 | Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay. | At Weeks 48 and 72 |
| Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72 | Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg. | At Weeks 48 and 72 |
| Bucharest |
| 022328 |
| Romania |
| Cluj-Napoca | 400162 | Romania |
| Constanța | Romania |
| Craiova | Romania |
| Iași | 700111 | Romania |
| Timișoara | 293406 | Romania |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72 | Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay. | Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 72 |
|
|
|
| Secondary | Percentage of Participants With Normal ALT at Week 48 | Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay. | ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 48 |
|
|
|
| Secondary | Percentage of Participants With Negative HDV RNA at Week 48 | Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay. | ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 48 |
|
|
|
| Secondary | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72 | Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1*10^5 copies/mL. | ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 48 and 72 |
|
|
|
| Secondary | Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels | Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay. | Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | Posted | Number | participants | At Screening and at Weeks 48 and 72 |
|
|
|
| Secondary | Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72 | Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay. | ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 48 and 72 |
|
|
|
| Secondary | Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72 | Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg. | ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 48 and 72 |
|
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| 0 |
| 0 |
| 0 |
| 0 |
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 |
| Title | Measurements |
|---|---|
|