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This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to patients with HBeAg-negative chronic hepatitis B in Morocco. Patients will receive Pegasys 180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during treatment and for 24 weeks of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alpha-2a, 180 mcg/48 weeks | Experimental | Eligible participants with HI3vAg (a type of Hepatitis B surface antigen) negative chronic hepatitis B will be administered peginterferon alpha-2a (PEGASYS), 40kD, 180 micrograms (mcg) subcutaneously once weekly for 48 weeks. The untreated Follow-up will be for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a [Pegasys] | Drug | 180 mcg subcutaneously weekly, 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72 | Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (at Week 72) were reported. | At Week 72 |
| Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72 | Percentage of participants with a normal serum alanine aminotransferase (ALT) level at the end of the study was analyzed. Normal ranges for ALT are 7 to 56 International Units/Litre. Participants with ALT less than the upper limit of normal at end of treatment were reported. | At Week 72 |
| Number of Participants With Any Adverse Events and Serious Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above | Up to Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72 | Participants who had HBV-DNA levels below 400 Copies/mL at the end of follow-up (at Week 72) were reported. | At Week 72 |
| Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48 |
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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 |
|---|---|---|---|---|---|---|
| Casablanca | 20100 | Morocco | ||||
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A total of 59 participants were enrolled in this study conducted from 13 January 2006 to 25 May 2009 at 9 centers in Kingdom of Morocco.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alpha-2a, 180 mcg/48 Weeks | Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered peg interferon alpha-2a (PEGASYS), 40 kilodalton (kD), 180 micrograms (mcg), subcutaneously, once weekly for 48 weeks. The untreated follow-up was for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis population included all the participants who received at least one dose of study medication and have one subsequent post baseline safety assessment
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alpha-2a, 180 mcg/48 Weeks | Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 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 Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72 | Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (at Week 72) were reported. | Intent-to-treat (ITT) population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 72 |
|
Up to Week 72
An AE is any untoward medical occurrence in a participant or clinical investigation that does not necessarily have to have a causal relationship with treatment. An AE can be unfavourable and unintended sign, symptom, or disease associated with a medicinal product, whether or not considered related to the medicinal product.
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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 | Peginterferon Alpha-2a, 180 mcg/ 48 Weeks | Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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Seroconversion is defined as the absence of hepatitis B surface antigen (HBsAg) with a negative result for HBsAg and the presence of anti-Haemoglobin (HBs) antibodies (a positive result for anti-HBs) determined at Week 48. Blood samples were analyzed to check whether it is HBsAg-negative and anti-HBs antibodies positive. |
| At Screening and Week 48 |
| Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72 | Percentage of participants showing normal ALT values and HBV DNA levels <10,000 copies/ mL were reported. | At Week 72 |
| Casablanca |
| Morocco |
| Rabat | 504 | Morocco |
| Rabat | 62000 | Morocco |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72 | Percentage of participants with a normal serum alanine aminotransferase (ALT) level at the end of the study was analyzed. Normal ranges for ALT are 7 to 56 International Units/Litre. Participants with ALT less than the upper limit of normal at end of treatment were reported. | ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 72 |
|
|
|
| Primary | Number of Participants With Any Adverse Events and Serious Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above | Safety analysis population is defined to include only participants who receive at least one dose of study medication and have one subsequent post baseline safety assessment. | Posted | Number | Participants | Up to Week 72 |
|
|
|
| Secondary | Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72 | Participants who had HBV-DNA levels below 400 Copies/mL at the end of follow-up (at Week 72) were reported. | ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 72 |
|
|
|
| Secondary | Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48 | Seroconversion is defined as the absence of hepatitis B surface antigen (HBsAg) with a negative result for HBsAg and the presence of anti-Haemoglobin (HBs) antibodies (a positive result for anti-HBs) determined at Week 48. Blood samples were analyzed to check whether it is HBsAg-negative and anti-HBs antibodies positive. | ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. 'n'=number of evaluable participants available at specified time point. | Posted | Number | Percentage of participants | At Screening and Week 48 |
|
|
|
| Secondary | Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72 | Percentage of participants showing normal ALT values and HBV DNA levels <10,000 copies/ mL were reported. | ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. Participants available at the time of assessment were included in the analysis. | Posted | Number | Percentage of participants | At Week 72 |
|
|
|
| 0 |
| 59 |
| 40 |
| 59 |
| Arthralgia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| 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 |
|---|---|
|
| Anti-HBs Positive, Week 48 (n= 55) |
|