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The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks after their treatment ends.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG 1.0 mcg/kg weekly (QW) * 24 weeks | Active Comparator | PegIntron 1.0 mcg/kg weekly (QW) * 24 weeks + 24 weeks follow-up |
|
| PEG 1.5 mcg/kg QW * 24 wks | Experimental | PegIntron 1.5 mcg/kg QW * 24 wks + 24 wks follow-up |
|
| PEG 1.5 mcg/kg QW * 48 wks | Experimental | PegIntron 1.5 mcg/kg QW * 48 wks + 24 wks follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegylated interferon alpha-2b | Drug | 1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss | HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA) | 24 weeks after end of treatment (EOT) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HBeAg Loss | HBeAg Loss was tested by assay of Abbott MEIA | Up to Treatment Week 48 |
| HBe Seroconversion | HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA. |
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Inclusion Criteria:
Adults with chronic hepatitis B:
Compensated liver disease with certain minimum hematological and serum biochemical criteria
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25200354 | Result | Cheng J, Wang Y, Hou J, Luo D, Xie Q, Ning Q, Ren H, Ding H, Sheng J, Wei L, Chen S, Fan X, Huang W, Pan C, Gao Z, Zhang J, Zhou B, Chen G, Wan M, Tang H, Wang G, Yang Y, Mohamed R, Guan R, Lee TH, Chang WH, Zhenfei H, Ye Z, Xu D. Peginterferon alfa-2b in the treatment of Chinese patients with HBeAg-positive chronic hepatitis B: a randomized trial. J Clin Virol. 2014 Dec;61(4):509-16. doi: 10.1016/j.jcv.2014.08.008. Epub 2014 Aug 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up |
| FG001 | PEG 1.5 mcg/kg QW * 24 Weeks | PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up |
| FG002 | PEG 1.5 mcg/kg QW * 48 Weeks | PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PEG 1.0 mcg/kg QW * 24 Weeks | PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up; treated participants |
| BG001 | PEG 1.5 mcg/kg QW * 24 Weeks | PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up; treated participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Treated Participants |
| 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 Hepatitis B Envelope Antigen (HBe or HBeAg) Loss | HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA) | Treated participants | Posted | Number | Participants | 24 weeks after end of treatment (EOT) |
|
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Population was all treated participants.
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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 | PEG 1.0 mcg/kg QW x24 Weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DEAFNESS UNILATERAL | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ASTHENIA | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| 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 |
|---|---|
| C417083 | peginterferon alfa-2b |
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| pegylated interferon alpha-2b | Drug | 1.5 mcg/kg S.C. QW for 24 weeks |
|
| pegylated interferon alpha-2b | Drug | 1.5 mcg/kg S.C. QW for 48 weeks |
|
| End of treatment (EOT) and 24 weeks after EOT |
| Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL | HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL) | End of treatment (EOT) and 24 weeks after EOT |
| Number of Participants With HBV-DNA < 200 IU/mL | HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL) | End of treatment (EOT) and 24 weeks after EOT |
| Number of Participants With HBV-DNA Undetectable | Undetectable HBV-DNA was defined as having a level <6 IU/mL by polymerase chain reaction (PCR). | End of treatment (EOT) and 24 weeks after EOT |
| Number of Participants With Biochemical Response | Biochemical response was defined as alanine aminotransferase (ALT) normalization. | End of treatment (EOT) and 24 weeks after EOT |
| Number of Participants With Combined Response | Combined response was defined as HBV DNA <20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization | End of treatment (EOT) and 24 weeks after EOT |
| Hepatitis B Surface Antigen (HBsAg) Loss | HBsAg Loss was tested by assay of Abbott MEIA | End of treatment (EOT) and 24 weeks after EOT |
| Hepatitis B Surface Antigen (HBs) Seroconversion | HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive | End of treatment (EOT) and 24 weeks after EOT |
| Change From Baseline in Liver Biopsy Score | Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System): Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis). Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked [involvement of >2/3 of lobules or nodules]). Score III (portal inflammation): 0 (none) to 4 (Marked [dense packing of inflammatory cells in >2/3 of portal tracts]). Score IV (fibrosis): 0 (none) to 4 (cirrhosis). | Baseline to 24 weeks after end of treatment |
| Subject withdrew - not treatment related |
|
| Subject withdrew - treatment related |
|
| Noncompliance with protocol |
|
| Did not meet protocol eligibility |
|
| BG002 | PEG 1.5 mcg/kg QW * 48 Weeks | PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up; treated participants. |
| BG003 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Treated Participants | Count of Participants | Participants |
|
PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up |
|
|
|
| Secondary | Number of Participants With HBeAg Loss | HBeAg Loss was tested by assay of Abbott MEIA | Treated participants | Posted | Number | Participants | Up to Treatment Week 48 |
|
|
|
|
| Secondary | HBe Seroconversion | HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA. | Treated participants | Posted | Number | Participants | End of treatment (EOT) and 24 weeks after EOT |
|
|
|
|
| Secondary | Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL | HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL) | Treated participants | Posted | Number | Participants | End of treatment (EOT) and 24 weeks after EOT |
|
|
|
|
| Secondary | Number of Participants With HBV-DNA < 200 IU/mL | HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL) | Treated participants | Posted | Number | Participants | End of treatment (EOT) and 24 weeks after EOT |
|
|
|
|
| Secondary | Number of Participants With HBV-DNA Undetectable | Undetectable HBV-DNA was defined as having a level <6 IU/mL by polymerase chain reaction (PCR). | Treated participants | Posted | Number | Participants | End of treatment (EOT) and 24 weeks after EOT |
|
|
|
|
| Secondary | Number of Participants With Biochemical Response | Biochemical response was defined as alanine aminotransferase (ALT) normalization. | Treated participants | Posted | Number | Participants | End of treatment (EOT) and 24 weeks after EOT |
|
|
|
|
| Secondary | Number of Participants With Combined Response | Combined response was defined as HBV DNA <20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization | Treated participants | Posted | Number | Participants | End of treatment (EOT) and 24 weeks after EOT |
|
|
|
|
| Secondary | Hepatitis B Surface Antigen (HBsAg) Loss | HBsAg Loss was tested by assay of Abbott MEIA | Treated participants | Posted | Number | Participants | End of treatment (EOT) and 24 weeks after EOT |
|
|
|
|
| Secondary | Hepatitis B Surface Antigen (HBs) Seroconversion | HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive | Treated participants | Posted | Number | Participants | End of treatment (EOT) and 24 weeks after EOT |
|
|
|
|
| Secondary | Change From Baseline in Liver Biopsy Score | Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System): Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis). Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked [involvement of >2/3 of lobules or nodules]). Score III (portal inflammation): 0 (none) to 4 (Marked [dense packing of inflammatory cells in >2/3 of portal tracts]). Score IV (fibrosis): 0 (none) to 4 (cirrhosis). | Treated participants from designated sites | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 24 weeks after end of treatment |
|
|
|
|
| 10 |
| 225 |
| 173 |
| 225 |
| EG001 | PEG 1.5 mcg/kg QW x24 Weeks | 11 | 221 | 169 | 221 |
| EG002 | PEG 1.5 mcg/kg QW x48 Weeks | 15 | 224 | 182 | 224 |
| OCULAR ICTERUS | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| HEPATIC PAIN | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| HEPATITIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| JAUNDICE CHOLESTATIC | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| HEPATITIS B | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| PARATYPHOID FEVER | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| THYROID FUNCTION TEST ABNORMAL | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| SPEECH DISORDER | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| AGGRESSION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| HALLUCINATION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| MANIA | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
The principal investigator (PI) agrees not to publish/present any interim results of the study without prior written consent of the sponsor. The PI further agrees to provide 45 days written notice to the sponsor prior to submission for publication/presentation to permit the sponsor to review copies of abstracts/manuscripts which report any study results. The sponsor shall have the right to review and comment. If the parties disagree the PI agrees to meet with the sponsor to discuss and resolve.
| 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 |
Stratified by genotype
| 0.125 |
| Pairwise rate difference |
| 0.054 |
| 2-Sided |
| 95 |
| -0.014 |
| 0.123 |
| Superiority or Other |
| Pairwise rate difference | -0.065 | 2-Sided | 90 | -0.122 | -0.008 | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cochran-Mantel-Haenszel |
Stratified by genotype |
| 0.24 |
| Pairwise rate difference |
| 0.041 |
| 2-Sided |
| 95 |
| -0.027 |
| 0.108 |
| Superiority or Other |
| End of treatment | Pairwise rate difference | -0.056 | 2-Sided | 90 | -0.112 | -0.001 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | 0.830 | Pairwise rate difference | -0.006 | 2-Sided | 95 | -0.075 | 0.063 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | 0.001 | Pairwise rate difference | 0.130 | 2-Sided | 95 | 0.053 | 0.208 | Superiority or Other |
| 24 weeks after EOT | Pairwise rate difference | -0.136 | 90 | -0.201 | -0.071 | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cochran-Mantel-Haenszel |
Stratified by genotype |
| 0.001 |
| Pairwise rate difference |
| 0.135 |
| 2-Sided |
| 95 |
| 0.053 |
| 0.216 |
| Superiority or Other |
| End of treatment | Pairwise rate difference | -0.063 | 2-Sided | 90 | -0.135 | 0.009 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | 0.662 | Pairwise rate difference | 0.017 | 2-Sided | 95 | -0.058 | 0.092 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | <0.001 | Pairwise rate difference | 0.139 | 2-Sided | 95 | 0.059 | 0.220 | Superiority or Other |
| 24 weeks after EOT | Pairwise rate difference | -0.122 | 2-Sided | 90 | -0.191 | -0.053 | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cochran-Mantel-Haenszel |
Stratified by genotype |
| 0.040 |
| Pairwise rate difference |
| 0.049 |
| 2-Sided |
| 95 |
| 0.003 |
| 0.096 |
| Superiority or Other |
| End of treatment | Pairwise rate difference | -0.030 | 2-Sided | 90 | -0.072 | 0.011 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | 0.969 | Pairwise rate difference | 0.001 | 2-Sided | 95 | -0.041 | 0.043 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | 0.074 | Pairwise rate difference | 0.045 | 2-Sided | 95 | -0.004 | 0.094 | Superiority or Other |
| 24 weeks after EOT | Pairwise rate difference | -0.044 | 2-Sided | 90 | -0.085 | -0.003 | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cochran-Mantel-Haenszel |
Stratified by genotype |
| 0.243 |
| Pairwise rate difference |
| 0.018 |
| 2-Sided |
| 95 |
| -0.012 |
| 0.048 |
| Superiority or Other |
| End of treatment | Pairwise rate difference | -0.022 | 2-Sided | 90 | -0.046 | 0.002 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | 0.724 | Pairwise rate difference | -0.004 | 2-Sided | 95 | -0.027 | 0.019 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | 0.232 | Pairwise rate difference | 0.018 | 2-Sided | 95 | -0.012 | 0.048 | Superiority or Other |
| 24 weeks after EOT | Pairwise rate difference | -0.022 | 2-Sided | 90 | -0.046 | 0.002 | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cochran-Mantel-Haenszel |
Stratified by genotype |
| 0.006 |
| Pairwise rate difference |
| 0.126 |
| 2-Sided |
| 95 |
| 0.037 |
| 0.216 |
| Superiority or Other |
| End of treatment | Pairwise rate difference | -0.071 | 2-Sided | 90 | -0.148 | 0.006 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | 0.067 | Pairwise rate difference | 0.082 | 2-Sided | 95 | -0.004 | 0.168 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | <0.001 | Pairwise rate difference | 0.180 | 2-Sided | 95 | 0.092 | 0.268 | Superiority or Other |
| 24 weeks after EOT | Pairwise rate difference | -0.098 | 2-Sided | 90 | -0.174 | -0.021 | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cochran-Mantel-Haenszel |
Stratified by genotype |
| 0.031 |
| Pairwise rate difference |
| 0.054 |
| 2-Sided |
| 95 |
| 0.005 |
| 0.103 |
| Superiority or Other |
| End of treatment | Pairwise rate difference | -0.053 | 2-Sided | 90 | -0.094 | -0.012 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | 0.389 | Pairwise rate difference | 0.024 | 2-Sided | 95 | -0.030 | 0.078 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | <0.001 | Pairwise rate difference | 0.121 | 2-Sided | 95 | 0.058 | 0.184 | Superiority or Other |
| 24 weeks after EOT | Pairwise rate difference | -0.097 | 2-Sided | 90 | -0.152 | -0.041 | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cochran-Mantel-Haenszel |
Stratified by genotype |
| 0.181 |
| Pairwise rate difference |
| 0.013 |
| 2-Sided |
| 95 |
| -0.006 |
| 0.033 |
| Superiority or Other |
| End of treatment | Pairwise rate difference | -0.013 | 2-Sided | 90 | -0.030 | 0.003 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | 0.971 | Pairwise rate difference | 0.000 | 2-Sided | 95 | -0.012 | 0.012 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | 0.179 | Pairwise rate difference | 0.013 | 2-Sided | 95 | -0.006 | 0.033 | Superiority or Other |
| 24 weeks after EOT | Pairwise rate difference | -0.013 | 2-Sided | 90 | -0.030 | 0.003 | Superiority or Other |
| Title | Measurements |
|---|---|
|
End of treatment
| Cochran-Mantel-Haenszel |
Stratified by genotype |
| 0.322 |
| Pairwise rate difference |
| 0.004 |
| 2-Sided |
| 95 |
| -0.004 |
| 0.013 |
| Superiority or Other |
| End of treatment | Pairwise rate difference | -0.004 | 2-Sided | 90 | -0.012 | 0.003 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype Due to zero responses in the 2 arms, pairwise rate difference & corresponding 95% confidence interval were not applicable. | 0.991 | 95 | Superiority or Other |
| 24 weeks after EOT | Cochran-Mantel-Haenszel | Stratified by genotype | 0.157 | Pairwise rate difference | 0.009 | 2-Sided | 95 | -0.003 | 0.021 | Superiority or Other |
| 24 weeks after EOT | Pairwise rate difference | -0.009 | 2-Sided | 90 | -0.019 | 0.001 | Superiority or Other |
|
| <0.001 |
| 95 |
| Superiority or Other |
| t-test, 2 sided | comparison of post-treatment versus baseline values | 0.010 | 95 | Superiority or Other |
| ANCOVA | Treatment group and genotype were the fixed effects and baseline was the covariate. | 0.631 | Pairwise rate difference | -0.2 | 2-Sided | 95 | -1.2 | 0.8 | Superiority or Other |
| ANCOVA | Treatment group and genotype were the fixed effects and baseline was the covariate. | 0.617 | Pairwise rate difference | -0.3 | 2-Sided | 95 | -1.4 | 0.8 | Superiority or Other |
| Pairwise rate difference | 0.0 | 2-Sided | 95 | -1.1 | 1.1 | Superiority or Other |