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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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A prospective, randomised, open-label phase IIb clinical trial assessing the effect of pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B
The primary objective of the trial is to investigate whether the add-on of pegylated interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48 weeks.
170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an oral antiviral regimen and having a nondetectable viral load for at least 12 months are included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | pegylated interferon alfa-2a (Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B |
|
| Control group | No Intervention | ongoing nucleos(t)ide based treatment alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated interferon alfa-2a plus nucleos(t)ide(s) | Drug | Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a ≥ 1log10 Decline of Quantitative HBsAg After 48 Weeks | Difference in percentage of patients between treatment and comparator arm reaching a ≥ 1log10 decline (tenfold reduction) of quantitative HBsAg after 48 weeks | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quantitative HBs Antigen at Week 12 | Change in quantitative HBs antigen at week 12. The data were log transformed before analysis and the changes to baseline were analysed. Therefore, the reported values might be interpreted as percentage changes. Lower scores mean a better outcome. | week 12 |
| Change in Quantitative HBs Antigen at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter R. Galle, Univ.-Prof. Dr. med. | I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facharztpraxis Prof. Löhr | Wiesbaden | Hesse | 65185 | Germany | ||
| Universitätsklinikum Aachen, Medizinische Klinik III |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Sprinzl MF, Grambihler A, Kittner JM, Wachtlin D, Ruckes C, et al. (2015) Prospective Randomized Open-label Trial Protocol Investigating the Addition of Pegylated Interferon-alpha to an Ongoing Nucleos(t)ide Treatment Regimen of HBeAg Negative Chronic Hepatitis B Patients (PADD-ON). J Clin Trials 5: 226. doi:10.4172/2167-0870.1000226 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | pegylated interferon alfa-2a (Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B Pegylated interferon alfa-2a plus nucleos(t)ide(s): Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s) |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2013 | Aug 28, 2018 |
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Change in quantitative HBs antigen at week 24. The data were log transformed before analysis and the changes to baseline were analysed. Therefore, the reported values might be interpreted as percentage changes. Lower scores mean a better outcome. |
| week 24 |
| Aachen |
| 52074 |
| Germany |
| Leber- und Studienzentrum am Checkpoint | Berlin | 10969 | Germany |
| Charité Campus Virchow Klinikum, Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn | Bonn | 53105 | Germany |
| Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum Universitätsklinikum Köln | Cologne | 50937 | Germany |
| Medizinisches Versorgungszentrum Dr. Mauss, Schmutz, Dr. Athmann, Dr. Hegener | Düsseldorf | 40237 | Germany |
| Medizinische Klinik I, Klinik der J.W. Goethe Universität | Frankfurt | 60590 | Germany |
| Teuber Consulting & Research KG | Frankfurt | 60594 | Germany |
| Universitätsklinikum Freiburg Innere Medizin II | Freiburg im Breisgau | 79106 | Germany |
| Universitätsklinikum Gießen und Marburg GmbH | Giessen | 35392 | Germany |
| Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik und Poliklinik | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie | Hanover | 30625 | Germany |
| Universitätsklinikum Heidelberg, Medizinische Klinik IV | Heidelberg | 69120 | Germany |
| Universitätsklinikum des Saarlandes | Homburg | 66421 | Germany |
| Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Allgemeine Innere Medizin | Kiel | 24105 | Germany |
| Universitätsklinikum Leipzig AöR | Leipzig | 04103 | Germany |
| Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik | Mainz | 55131 | Germany |
| Universitätsklinikum Mannheim | Mannheim | 68167 | Germany |
| Klinikum rechts der Isar der Technischen Universität München | München | 81675 | Germany |
| Universitätsklinikum Regensburg | Regensburg | 93053 | Germany |
| Uniklinik Tübingen Innere Medizin Abt. I | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm, Zentrum für Innere Medizin | Ulm | 89081 | Germany |
| Klinikum der Universität Würzburg Zentrum für Innere Medizin (ZIM) Medizinische Klinik und Poliklinik II Leber- und Infektionsambulanz | Würzburg | 97080 | Germany |
| Control Group |
ongoing nucleos(t)ide based treatment alone |
| COMPLETED |
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| NOT COMPLETED |
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The Baseline Analysis Population is the modified ITT population consisting of all randomized patients with at least one available post-baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | pegylated interferon alfa-2a (Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B Pegylated interferon alfa-2a plus nucleos(t)ide(s): Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s) |
| BG001 | Control Group | ongoing nucleos(t)ide based treatment alone |
| BG002 | Total | Total of all reporting groups |
| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Virology: HBV DNA quant. negative? | Count of Participants | Participants |
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| Virology: Anti-HBs | Count of Participants | Participants |
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| Virology: HBeAg | Count of Participants | Participants |
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| Virology: Anti-HBe | Measure was not determined by the laboratory in 3 cases. | Count of Participants | Participants |
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| Virology: Anti-HBc | Measure was not determined by the laboratory in one case. | Count of Participants | Participants |
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| Virology: HCV | Count of Participants | Participants |
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| Virology: HDV | Count of Participants | Participants |
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| Virology: HIV | Measure was not determined by the laboratory in one case. | Count of Participants | Participants |
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| HBV Genotype known? | Count of Participants | Participants |
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| HBV Genotype | The Genotype was only available in 34 patients. | Count of Participants | Participants |
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| HBsAG Concentration | HBsAG was not determined by the laboratory in 4 patients. | Mean | Standard Deviation | IU/mL |
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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 | Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a ≥ 1log10 Decline of Quantitative HBsAg After 48 Weeks | Difference in percentage of patients between treatment and comparator arm reaching a ≥ 1log10 decline (tenfold reduction) of quantitative HBsAg after 48 weeks | mITT population consisting of all randomized patients with at least one post-baseline measurement | Posted | Count of Participants | Participants | 48 weeks |
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| Secondary | Change in Quantitative HBs Antigen at Week 12 | Change in quantitative HBs antigen at week 12. The data were log transformed before analysis and the changes to baseline were analysed. Therefore, the reported values might be interpreted as percentage changes. Lower scores mean a better outcome. | Values were only available in 154 patients. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | IU/ml | week 12 |
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| Secondary | Change in Quantitative HBs Antigen at Week 24 | Change in quantitative HBs antigen at week 24. The data were log transformed before analysis and the changes to baseline were analysed. Therefore, the reported values might be interpreted as percentage changes. Lower scores mean a better outcome. | Values were only available in 151 patients. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | IU/ml | week 24 |
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48 weeks
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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 | Treatment Group | pegylated interferon alfa-2a (Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B Pegylated interferon alfa-2a plus nucleos(t)ide(s): Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s) | 0 | 112 | 13 | 112 | 106 | 112 |
| EG001 | Control Group | ongoing nucleos(t)ide based treatment alone | 0 | 58 | 4 | 58 | 20 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
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| Aortic valve stenosis | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
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| forearm fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
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| facial bones fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
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| retinal haemorrhage | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
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| internal fixation of fracture | Surgical and medical procedures | MedDRA (20.1) | Non-systematic Assessment |
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| coronary artery disease | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
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| renal colic | Renal and urinary disorders | MedDRA (20.1) | Non-systematic Assessment |
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| chlamydial infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| hyperthyroidism | Endocrine disorders | MedDRA (20.1) | Non-systematic Assessment |
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| lymphadenopathy | Blood and lymphatic system disorders | MedDRA (20.1) | Non-systematic Assessment |
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| hepatocellular lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Non-systematic Assessment |
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| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| pain | General disorders | MedDRA (20.1) | Non-systematic Assessment |
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| pyelonephritis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| urinary tract infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (20.1) | Non-systematic Assessment |
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| vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (20.1) | Non-systematic Assessment |
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| nasal tubinate hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chills | General disorders | MedDRA (20.1) | Non-systematic Assessment |
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| fatigue | General disorders | MedDRA (20.1) | Non-systematic Assessment |
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| influenza like illness | General disorders | MedDRA (20.1) | Non-systematic Assessment |
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| injection site erythema | General disorders | MedDRA (20.1) | Non-systematic Assessment |
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| pyrexia | General disorders | MedDRA (20.1) | Non-systematic Assessment |
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| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| nasopharyngitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| dizziness | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
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| headache | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
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| alopecia | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| dry skin | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| insomnia | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| transaminases increased | Investigations | MedDRA (20.1) | Non-systematic Assessment |
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| weight decreased | Investigations | MedDRA (20.1) | Non-systematic Assessment |
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| thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Non-systematic Assessment |
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| decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
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| erectile dysfunction | Reproductive system and breast disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christian Ruckes | IZKS of the University Medical Center of the Johannes Gutenberg University Mainz | +49 6131 17 | 9919 | ruckes@izks-mainz.de |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2017 | Aug 28, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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The Fisher Test with asymptotic test statistic provided by the analysis software was used. |
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