Trial Outcomes & Findings for An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chronic Hepatitis B (NCT NCT01787279)

Results Overview

Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (at Week 72) were reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

59 participants

Primary outcome timeframe

At Week 72

Results posted on

2016-07-22

Participant Flow

A total of 59 participants were enrolled in this study conducted from 13 January 2006 to 25 May 2009 at 9 centers in Kingdom of Morocco.

Participant milestones

Participant milestones
Measure	Peginterferon Alpha-2a, 180 mcg/48 Weeks Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered peg interferon alpha-2a (PEGASYS), 40 kilodalton (kD), 180 micrograms (mcg), subcutaneously, once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
Overall Study STARTED	59
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Peginterferon Alpha-2a, 180 mcg/48 Weeks Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered peg interferon alpha-2a (PEGASYS), 40 kilodalton (kD), 180 micrograms (mcg), subcutaneously, once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
Overall Study Lost to Follow-up	2
Overall Study Lack of Efficacy	1

Baseline Characteristics

An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chronic Hepatitis B

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peginterferon Alpha-2a, 180 mcg/48 Weeks n=59 Participants Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
Age, Continuous	41 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 72

Population: Intent-to-treat (ITT) population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.

Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (at Week 72) were reported.

Outcome measures

Outcome measures
Measure	Peginterferon Alpha-2a, 180 mcg/48 Weeks n=59 Participants Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72	65.4 Percentage of participants Interval 52.5 to 78.3

PRIMARY outcome

Timeframe: At Week 72

Population: ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.

Percentage of participants with a normal serum alanine aminotransferase (ALT) level at the end of the study was analyzed. Normal ranges for ALT are 7 to 56 International Units/Litre. Participants with ALT less than the upper limit of normal at end of treatment were reported.

Outcome measures

Outcome measures
Measure	Peginterferon Alpha-2a, 180 mcg/48 Weeks n=59 Participants Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72	68.6 Percentage of participants Interval 56.8 to 80.4

PRIMARY outcome

Timeframe: Up to Week 72

Population: Safety analysis population is defined to include only participants who receive at least one dose of study medication and have one subsequent post baseline safety assessment.

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above

Outcome measures

Outcome measures
Measure	Peginterferon Alpha-2a, 180 mcg/48 Weeks n=59 Participants Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
Number of Participants With Any Adverse Events and Serious Adverse Events Any AE	46 Participants
Number of Participants With Any Adverse Events and Serious Adverse Events Any SAE	0 Participants

SECONDARY outcome

Timeframe: At Week 72

Population: ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.

Participants who had HBV-DNA levels below 400 Copies/mL at the end of follow-up (at Week 72) were reported.

Outcome measures

Outcome measures
Measure	Peginterferon Alpha-2a, 180 mcg/48 Weeks n=59 Participants Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72	26.9 Percentage of participants Interval 14.8 to 39.0

SECONDARY outcome

Timeframe: At Screening and Week 48

Population: ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. 'n'=number of evaluable participants available at specified time point.

Seroconversion is defined as the absence of hepatitis B surface antigen (HBsAg) with a negative result for HBsAg and the presence of anti-Haemoglobin (HBs) antibodies (a positive result for anti-HBs) determined at Week 48. Blood samples were analyzed to check whether it is HBsAg-negative and anti-HBs antibodies positive.

Outcome measures

Outcome measures
Measure	Peginterferon Alpha-2a, 180 mcg/48 Weeks n=59 Participants Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48 HBs-Ag Negative, Screening (n= 59)	1.7 Percentage of participants
Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48 HBs-Ag Negative, Week 48 (n= 55)	10.9 Percentage of participants
Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48 Anti-HBs Positive, Screening (n= 59)	0 Percentage of participants
Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48 Anti-HBs Positive, Week 48 (n= 55)	10.9 Percentage of participants

SECONDARY outcome

Timeframe: At Week 72

Population: ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. Participants available at the time of assessment were included in the analysis.

Percentage of participants showing normal ALT values and HBV DNA levels \<10,000 copies/ mL were reported.

Outcome measures

Outcome measures
Measure	Peginterferon Alpha-2a, 180 mcg/48 Weeks n=51 Participants Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72	58.8 Percentage of participants

Adverse Events

Peginterferon Alpha-2a, 180 mcg/ 48 Weeks

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Peginterferon Alpha-2a, 180 mcg/ 48 Weeks n=59 participants at risk Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
General disorders Asthenia	39.0% 23/59 • Up to Week 72 An AE is any untoward medical occurrence in a participant or clinical investigation that does not necessarily have to have a causal relationship with treatment. An AE can be unfavourable and unintended sign, symptom, or disease associated with a medicinal product, whether or not considered related to the medicinal product.
General disorders Arthralgia	6.8% 4/59 • Up to Week 72 An AE is any untoward medical occurrence in a participant or clinical investigation that does not necessarily have to have a causal relationship with treatment. An AE can be unfavourable and unintended sign, symptom, or disease associated with a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders Anxiety	8.5% 5/59 • Up to Week 72 An AE is any untoward medical occurrence in a participant or clinical investigation that does not necessarily have to have a causal relationship with treatment. An AE can be unfavourable and unintended sign, symptom, or disease associated with a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders Insomnia	11.9% 7/59 • Up to Week 72 An AE is any untoward medical occurrence in a participant or clinical investigation that does not necessarily have to have a causal relationship with treatment. An AE can be unfavourable and unintended sign, symptom, or disease associated with a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders Neutropenia	15.3% 9/59 • Up to Week 72 An AE is any untoward medical occurrence in a participant or clinical investigation that does not necessarily have to have a causal relationship with treatment. An AE can be unfavourable and unintended sign, symptom, or disease associated with a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders Myalgia	6.8% 4/59 • Up to Week 72 An AE is any untoward medical occurrence in a participant or clinical investigation that does not necessarily have to have a causal relationship with treatment. An AE can be unfavourable and unintended sign, symptom, or disease associated with a medicinal product, whether or not considered related to the medicinal product.

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 616878333

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