A Phase 4 interventional study of PegIFN alfa-2a in Hepatitis B, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-01-01.
Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Phase 4, Interventional, and Treatment
This study evaluates whether PegIFN alfa-2a add on can improve CHB patients HBsAg clearance at the end of 48 weeks treatment. The CHB patients who received nucleot(s)ides anti-virus treatment and reached HBV DNA\<1000 copies/ml and HBsAg\<3000 IU/ml, were randomly assigned into two groups: One group continue the nucleot(s)ides treatment for 72 weeks, the other add on PegIFN alfa-2a on the basis of the original treatment for 48 weeks, and follow up for 24 weeks.
nucleot(s)ides is a potent inhibitor of hepatitis B viral(HBV) replication, but long-term therapy may be required, and it is difficult for CHB patients to achieve HBsAg clearance by using nucleot(s)ides. Therefore, it is need take long-term therapy if chronic hepatitis B (CHB) choose to use nucleot(s)ides, and in another way, nucleot(s)ides resistance is an important clinical risk. More and more young patients want to stop treating, and discontinuation of nucleot(s)ides is a feasible strategy to reduce resistance. However, it is really easy to relapse if patients did not arrive HBsAg clearance. PegIFN alfa-2a can clear HBV by direct anti-viral and immune regulation mechanisms including enhancing natural killer cell response, increased cluster of differentiation 8(CD8 +) T lymphocytes and other mechanisms to restore and enhance the immune response in patients with CHB; and what's more, patients are safety after discontinuing.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's planned enrollment of 196 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →The Second Affiliated Hospital of Chongqing Medical University is the lead sponsor of 98 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients who treated with nucleot(s)ides (including lamivudine, adefovir, entecavir, tenofovir) are still using the original treatment for 72 weeks
patients who treated with nucleot(s)ides (including lamivudine, adefovir, entecavir, tenofovir), then will add PegIFN alfa-2a to the original nucleot(s)ides for 48 weeks, then follow up for 24 weeks
Drug: PegIFN alfa-2a
chronic hepatitis B patients who treated with nucleot(s)ides (including lamivudine, adefovir, entecavir, tenofovir) arrived HBV DNA \<1000copies/ml, and HBsAg\<3000IU/ml, then change the treatment to original nucleot(s)ides add on PegIFN alfa-2a, the combined treatment is for 48 weeks, and follow up for 24 weeks
Also known as: Pegasys
Number of participants who achieve HBsAg clearance
To investigate whether Peg-IFN alfa-2a add on treatment can improve the HBsAg clearance in CHB patients at the end of the treatment (48 week).
Time frame: treat for 48 weeks
Number of participants who achieve HBsAg seroconversion
To investigate whether Peg-IFN alfa-2a add on treatment can improve the HBsAg seroconversion in CHB patients at the end of the treatment (48 week).
Time frame: 48 weeks
Number of participants who achieve HBeAg clearance and seroconversion
To investigate whether Peg-IFN alfa-2a add on treatment can improve HBeAg clearance and seroconversion at the end of the treatment (48 week).
Time frame: 48 weeks
HBsAg changes from Baseline
Pegasys 24 weeks Group:12,24 weeks and Pegasys 48 weeks Group:12,24,48 weeks
Time frame: 12,24 and 48 weeks
Number of participants who achieve HBV DNA<1000 copies/ml
To investigate whether Peg-IFN alfa-2a add on treatment can improve HBV DNA\<1000 copies/ml
Time frame: 12,24 and 48 weeks
No study locations are listed for this record.
Plan to share: Undecided — still undecided
This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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The Second Affiliated Hospital of Chongqing Medical University