N/A
N=1,669
A Study to Collect Blood Biomarker Samples From Participants With Chronic Hepatitis B (CHB) Who Received Treatment With Pegasys (Peginterferon Alfa-2a) ± Nucleoside/Nucleotide Analogue
Hepatitis B, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01855997 ↗Enrolled (actual)
1,669
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model — 2.1010; 1.8580; 1.8330; 1.8590 beta coefficient — p=0.00000559
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Peg-IFN alfa-2a (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model |
2.1010; 1.8580; 1.8330; 1.8590; 1.8340; 1.8120 | 0.00000559 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model |
2.2030; 2.1200; 0.4876; 0.4501; 0.4644 | 0.00000987 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model |
2.7870; 1.7250; 1.7410; 0.5740; 0.5683 | 0.00000677 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model |
3.0040; 0.4873; 0.5002 | 0.00000459 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model |
1.8610; 1.9390; 1.8360; 1.9060; 1.9240; 0.3363 | 0.00000470 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model |
2.6700; 2.3000; 3.0120; 0.3108 | 0.00000666 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model |
1.8610; 2.8290 | 0.00000207 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model |
2.6260; 2.2220; 2.9500; 0.4639 | 0.00000573 sig |
| PRIMARY SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model |
4.3170 | 0.00000016 sig |
| PRIMARY SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model |
4.2450 | 0.00000088 sig |
| PRIMARY SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model |
0.2583 | 0.00000879 sig |
| PRIMARY SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model |
0.1812; 5.8110; 5.8110 | 0.00000452 sig |
| PRIMARY SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model |
0.1070; 0.3357; 2.0360; 1.9480; 2.0100 | 0.00000748 sig |
| PRIMARY SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model |
0.2975; 0.1009; 2.3660; 2.3610; 0.3186; 0.1299 | 0.00000627 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model |
2.9930; 0.5024; 0.5078 | 0.00000153 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model |
3.1610 | 0.00000397 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model |
1.6780; 0.6008; 1.6680 | 0.00000686 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model |
0.5360; 0.4869; 1.8700 | 0.00000834 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model |
0.6617; 1.5160; 1.7220; 0.5957; 0.6814; 1.5540 | 0.00000137 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model |
0.5664; 0.5576; 1.7050; 0.5732; 1.6850 | 0.00000846 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model |
2.8740; 0.5000 | 0.00000368 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model |
0.3719; 2.6740 | 0.00000950 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model |
0.5565; 0.5565; 0.5565; 0.5730; 1.8390; 0.5769 | 0.00000805 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model |
1.9800; 0.5036; 0.5029; 2.3190; 0.4634 | 0.00000629 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model |
0.6444; 0.6621 | 0.00000118 sig |
| PRIMARY SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model |
0.5210; 1.7610; 0.5233; 1.7460 | 0.00000593 sig |
| PRIMARY SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model |
5.7670 | 0.00000558 sig |
| PRIMARY SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model |
8.6340 | 0.00000990 sig |
| PRIMARY SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model |
8.2240 | 0.00000048 sig |
| PRIMARY SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model |
8.2240 | 0.00000048 sig |
| PRIMARY SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model |
0.4571; 2.1090; 6.6180; 2.9650 | 0.00000738 sig |
| PRIMARY SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model |
7.8720 | 0.00000720 sig |
Summary
This Phase 4 study is designed for the collection of blood biomarker samples from participants who have completed CHB treatment with at least 24 weeks of a pegylated interferon alfa-2a (Peg-IFN alfa-2a) containing regimen and at least 24 weeks post-treatment follow-up. Participants may be enrolled from historical studies supported or sponsored by Roche, ongoing studies supported or sponsored by Roche, or from general medical practice. The follow-up of individuals who choose to participate in this study will be in accordance with the ongoing studies or with the general medical practice of the physician. Data from whole blood deoxyribonucleic acid (DNA) samples collected in the GV28555 study or available from previously collected Roche Clinical Repository (RCR) samples will be used for combined analysis with data from other applicable studies. Procedures will include blood sample collection (not applicable for participants who previously have consented and donated RCR DNA samples) and medical record capture.
Eligibility Criteria
Inclusion Criteria
- Adults greater than or equal to (≥) 18 years of age
- CHB
- Previously enrolled in a Roche study and treated for CHB for ≥24 weeks with Peg-IFN ± nucleoside analogue (lamivudine or entecavir) or Peg-IFN ± nucleotide analogue (adefovir) and with ≥24 weeks post-treatment follow-up; or
- Treated in general practice for CHB with Peg-IFN according to standard of care and in line with the current Summary of Product Characteristics (SmPC)/local labeling who have no contraindication to Peg-IFN therapy as per local label and have been treated with Peg-IFN for ≥24 weeks and have ≥24 week post-treatment response available at the time of blood sample collection
Exclusion Criteria
- Hepatitis A, hepatitis C, or human immunodeficiency virus (HIV) infection
Data sourced from ClinicalTrials.gov (NCT01855997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.