Trial Outcomes & Findings for Pegylated Interferon to Treat Chronic Hepatitis D (NCT NCT00023322)

NCT ID: NCT00023322

Last Updated: 2013-07-10

Results Overview

Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2013-07-10

Participant Flow

Between October 2002 and June 2006, 13 patients were recruited into the study. The location is NIH clinical center.

Participant milestones

Measure	Peginterferon Alpha-2a Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Peginterferon Alpha-2a Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Pegylated Interferon to Treat Chronic Hepatitis D

Baseline characteristics by cohort

Measure	Peginterferon Alpha-2a n=13 Participants Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
Age Continuous	42 years n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	11 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	13 participants n=93 Participants
Estimated duration of the disease	25 years n=93 Participants
ALT	141 IU/L n=93 Participants
Infection source IV Drug Abuse	6 participants n=93 Participants
Infection source Sexual	2 participants n=93 Participants
Infection source Transfusion	2 participants n=93 Participants
Infection source Endemic Region	5 participants n=93 Participants
HDV-RNA	6.7 Log10 Genome Equivalent/ml STANDARD_DEVIATION 1.2 • n=93 Participants
HBsAg	3.7 Log10 IU/ml STANDARD_DEVIATION 0.6 • n=93 Participants
HBV-DNA	2.9 Log10 IU/ml n=93 Participants
Fibrosis (Ishak score)	3 Scores on a scale n=93 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Intention to treat

Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.

Outcome measures

Measure	Peginterferon Alpha-2a n=12 Participants Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
Histological Response at 3 Years	6 participants

SECONDARY outcome

Timeframe: 5 years

Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.

Outcome measures

Measure	Peginterferon Alpha-2a n=12 Participants Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
Histological Response at 5 Years	6 participants

Adverse Events

Peginterferon Alpha-2a

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Peginterferon Alpha-2a n=12 participants at risk Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
Hepatobiliary disorders Death	8.3% 1/12 • Number of events 1

Other adverse events

Measure	Peginterferon Alpha-2a n=12 participants at risk Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
Skin and subcutaneous tissue disorders soft tissue infection	8.3% 1/12 • Number of events 1
Infections and infestations autoinflammatory syndrome	8.3% 1/12 • Number of events 1
Blood and lymphatic system disorders subarachnoid hemorrhage	8.3% 1/12 • Number of events 1

Additional Information

Theo Heller, M.D.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Phone: (301) 402-7147

Email: Theoh@mail.nih.gov

Results disclosure agreements

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