NASVAC Phase-III Trial in Chronic Hepatitis B (CHB) Patients

NCT01374308 | Unknown Phase 3

• 1 other identifier: NASVAC01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The general objective of the present clinical trial is to compare the therapeutic efficacy of a combination therapeutic vaccine containing hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) \[later called NASVAC\] with a commonly used antiviral drug, pegylated interferon in patients with chronic hepatitis B (CHB).

Conditions

Chronic Hepatitis B

Keywords

NASVAC; Pegylated Interferon-2b; CHB

Outcome Measures

Primary Outcomes (1)

• Number of study participants with virological and or biochemical response as a measure of efficacy

  At week 96

Study Arms (2)

NASVAC

EXPERIMENTAL

NASVAC will be administered every 2 weekly intra-nasally at a dose of 100 micro grams for 5 times followed by every 2 weekly administration of 100 micro grams intra-nasally plus 100 micro grams subcutaneously.

Biological: NASVAC

Pegylated interferon alpha 2b

ACTIVE COMPARATOR

Injection Pegylated interferon alpha 2b will be administered once weekly subcutaneously at a dose of 180 micro grams for 48 weeks

Drug: Pegylated interferon alpha 2b

Interventions

NASVAC BIOLOGICAL

NASVAC will be administered every 2 weekly intra-nasally at a dose of 100 micro grams for 5 times followed by every 2 weekly administration of 100 micro grams intra-nasally plus 100 micro grams subcutaneously.

NASVAC

Pegylated interferon alpha 2b DRUG

Injection Pegylated interferon alpha 2b will be administered once weekly subcutaneously at a dose of 180 micro grams for 48 weeks

Also known as: Pegasys, Pegintron, Pegin, Optipeg, Peghebron

Pegylated interferon alpha 2b

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HBsAg+ serology for more than 6 months before the beginning of the treatment.
• In the last six months, according to HBeAg serostatus, for:
• HBeAg (-) patients, with a) baseline HBV DNA ≥ 103 and b) raised serum ALT (x \>1 ULN) or significant hepatic necroinflammation and/or fibrosis (HAI-NI\>4 and/or HAI-F \>2) or liver stiffness \>7.2 KPa.
• HBeAg (+) patients, with a) baseline HBV DNA ≥ 104 and b) and raised serum ALT (x \>1.5 ULN) or significant hepatic necroinflammation and or fibrosis (HAI-NI\>4 and/or HAI-F \>2) or liver stiffness \>7.2 KPa.
• Patients of both sex from 18 to 60 years-old
• Voluntary signed informed consent to participate in the trial

You may not qualify if:

• Condition of HBV asymptomatic carrier or cirrhosis or patients with primary hepatocellular carcinoma
• Positive serological markers for hepatitis C
• Positive serological markers for HIV
• Previous specific anti-hepatitis B treatment in the last 6 months.
• Critically ill patient history of heart or renal failure, hypertension, hyperthyroidism, epilepsy, immunodeficiency diseases, malignancies or any non-controlled systemic disease.
• Pregnancy or nursing women. Women in fertile age without any contraceptive methods.
• Known severe allergic conditions (degree III or IV asthma, urticaria, dermatitis, bronchitis, etc. or hypersensitivity to any of the ingredients present in the preparation).
• Severe psychiatric dysfunction or another limitation that prevents the patient's consent.
• History of Autoimmune diseases (such as SLE, rheumatoid arthritis, multiple sclerosis, non controlled diabetes mellitus type 1)
• History of other hepatic diseases of different etiology (such as alcoholism, autoimmune hepatitis, drug induced hepatitis, Wilson's diseases, hemochromatosis)
• History of immune suppressive disorder or administration of immune suppressive-immune modulator drugs (including steroids) during or in the 6 months previous to the study.
• Very high transaminase levels at the beginning of treatment (ALT over 500 U/L) suggesting a not stable disease with risk for patient's health or acute flares over 15 times the upper limit of normality.

Sponsors & Collaborators

• Clinical Research Organization, Dhaka, Bangladesh: lead

Study Sites (1)

Farabi General Hospital

Dhaka, 1207, Bangladesh

Location

Related Publications (1)

• Al Mahtab M, Akbar SMF, Aguilar JC, Guillen G, Penton E, Tuero A, Yoshida O, Hiasa Y, Onji M. Treatment of chronic hepatitis B naive patients with a therapeutic vaccine containing HBs and HBc antigens (a randomized, open and treatment controlled phase III clinical trial). PLoS One. 2018 Aug 22;13(8):e0201236. doi: 10.1371/journal.pone.0201236. eCollection 2018.

  PMID: 30133478 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a; peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mamun A Mahtab, MSc MD FACG

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2011
• First Posted: June 15, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

BA (1)