Trial Outcomes & Findings for An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B (NCT NCT01667432)

Results Overview

Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).

Recruitment status

COMPLETED

Target enrollment

141 participants

Primary outcome timeframe

At the end of the study (Week 36)

Results posted on

2017-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Peginterferon Alfa-2a Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
Overall Study STARTED	141
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Peginterferon Alfa-2a Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
Overall Study Premature Study Termination	26
Overall Study Failure to Return	10
Overall Study Moved to Another Center	3
Overall Study Lost to Follow-up	3
Overall Study Refused Treatment/Withdrew Consent	1
Overall Study Insufficient Therapeutic Response	4
Overall Study Adverse Event	1
Overall Study Protocol Deviation	2
Overall Study Principal Investigator Decision	1
Overall Study Reason Not Specified	2
Overall Study Missing Information	4

Baseline Characteristics

An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peginterferon Alfa-2a n=139 Participants Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
Age, Continuous	40.10 years STANDARD_DEVIATION 10.45 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	119 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of the study (Week 36)

Population: Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.

Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a n=139 Participants Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.
Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study	38.8 Percentage of participants Interval 30.7 to 47.48

PRIMARY outcome

Timeframe: approximately 3 years

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: approximately 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the end of treatment (Week 24)

Population: Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a. Only participants with available HBsAg measurements were included in the analysis.

Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a n=37 Participants Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.
Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment HBeAg positive (n = 4)	36.4 percentage of participants Interval 10.92 to 69.21
Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment HBeAg negative (n = 33)	26.6 percentage of participants Interval 19.8 to 35.3

SECONDARY outcome

Timeframe: approximately 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: approximately 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: approximately 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: approximately 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: approximately 3 years

Outcome measures

Outcome data not reported

Adverse Events

Peginterferon Alfa-2a

Serious events: 1 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Peginterferon Alfa-2a n=139 participants at risk Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
Skin and subcutaneous tissue disorders Rash	0.72% 1/139 • Number of events 1 Safety population: All participants who received at least 1 dose of peginterferon alfa-2a and had at least 1 post-baseline safety assessment.

Other adverse events

Other adverse events
Measure	Peginterferon Alfa-2a n=139 participants at risk Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
Blood and lymphatic system disorders Leucopenia	16.5% 23/139 • Number of events 23 Safety population: All participants who received at least 1 dose of peginterferon alfa-2a and had at least 1 post-baseline safety assessment.
Hepatobiliary disorders Hypertransaminasaemia	5.0% 7/139 • Number of events 7 Safety population: All participants who received at least 1 dose of peginterferon alfa-2a and had at least 1 post-baseline safety assessment.
Blood and lymphatic system disorders Thrombocytopenia	19.4% 27/139 • Number of events 27 Safety population: All participants who received at least 1 dose of peginterferon alfa-2a and had at least 1 post-baseline safety assessment.
General disorders Fever	30.2% 42/139 • Number of events 42 Safety population: All participants who received at least 1 dose of peginterferon alfa-2a and had at least 1 post-baseline safety assessment.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER