Trial Outcomes & Findings for An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam (NCT NCT01886300)
NCT ID: NCT01886300
Last Updated: 2016-06-22
Results Overview
A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to \<2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.
TERMINATED
16 participants
6 months
2016-06-22
Participant Flow
Out of 335 participants planned to be enrolled in the study, only 16 participants were enrolled. The trial was conducted at 8 centers in Vietnam.
Participant milestones
| Measure |
Peginterferon Alfa-2a
Participants with hepatitis B envelope antigen (HBeAg) positive chronic hepatitis B who received peginterferon alfa-2a \[Pegasys\] were included.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Peginterferon Alfa-2a
Participants with hepatitis B envelope antigen (HBeAg) positive chronic hepatitis B who received peginterferon alfa-2a \[Pegasys\] were included.
|
|---|---|
|
Overall Study
Trial terminated by sponsor
|
16
|
Baseline Characteristics
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam
Baseline characteristics by cohort
| Measure |
Peginterferon Alfa-2a
n=16 Participants
Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
|
|---|---|
|
Age, Continuous
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to \<2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 monthsPopulation: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
HBeAg is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
A participant was considered to have achieved suppression of HBV DNA to \<2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
Loss of HBeAg is defined as the absence of HBeAg. A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) 'NEGATIVE' or (b) a quantitative result was lower than the reported lower detection limit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
HBeAg seroconversion is defined as the absence of HBeAg and the presence of antibody to hepatitis B antigen (anti-HBe) . A participant was considered to have achieved suppression of HBV DNA to \<2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
HBeAg is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
Normalization of alanine transaminase (ALT) values means that ALT values out of the normal range returned to within the normal range.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Participants present at the time of assessment were used for analysis.
An AE is any untoward medical occurrence in a patient or clinical investigation patient 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
Outcome measures
| Measure |
Peginterferon Alfa-2a
n=16 Participants
Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
|
|---|---|
|
Number of Participants With Incidence of Adverse Events
|
9 Number of participants
|
Adverse Events
Peginterferon Alfa-2a
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Peginterferon Alfa-2a
n=16 participants at risk
Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
|
|---|---|
|
Investigations
Increasing HBV DNA
|
6.2%
1/16 • Up to 24 months
|
|
Investigations
Weight loss
|
12.5%
2/16 • Up to 24 months
|
|
General disorders
Fatigue
|
6.2%
1/16 • Up to 24 months
|
|
General disorders
Fever
|
6.2%
1/16 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
2/16 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Up to 24 months
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Up to 24 months
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Up to 24 months
|
|
Eye disorders
Blurred Vision
|
6.2%
1/16 • Up to 24 months
|
|
Infections and infestations
Flu symptom
|
6.2%
1/16 • Up to 24 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.8%
3/16 • Up to 24 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
1/16 • Up to 24 months
|
|
Hepatobiliary disorders
Transaminase Flare
|
6.2%
1/16 • Up to 24 months
|
|
Psychiatric disorders
Libido
|
12.5%
2/16 • Up to 24 months
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
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