To Study the Effect of Adding on Pegylated Interferon (PEG-INF) Therapy for Patients Diagnosed With Chronic Hepatitis B

NCT02982837 | Unknown Phase 4

• 1 other identifier: PDU15001
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 3

Brief Summary

To assess whether PEG-INF (Peglyated - interferon) Add-on therapy in patients of CHB who have achieved a maintained viral suppression (HBV DNA PCR( polymerase chain reaction) \<200 for last 3-6 month) with NA's can result in increased rate of HBV infection eradication (HbsAg is undetectable by serological blood testing with or without seroconversion to HBs antibody).

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• The loss of HbsAg between groups (NA) group and NA +Peg_INF group assessed by HbsAg test

  The loss of HbsAg between groups (NA) group and NA +Peg\_INF group assessed by HbsAg test

  48 weeks

Secondary Outcomes (7)

• The seroconversion to HBs antibody between groups (NA) group and NA +Peg_INF group assessed by Hbe Ab test

  6 ,12 months & 48 weeks

• The HBeAg (Hepatitis B e-Antigen) loss in CHRONIC HBV eAg positive patient between groups (NA) group and NA +Peg_INF group assessed by HbeAg test

  6,12 months & 48 weeks

• The conversion of HBeAg to HBe-antibody in CHRONIC HBV eAg (eAntigen) positive patient between groups (NA) group and NA +Peg_INF group assessed by HBe-antibody test

  6,12 months & 48 weeks

• The correlation between HBsAg ( Hepatitis B Surface Antigen) levels while on therapy at the a defined interval ie 8,12.24,36,48 weeks and rate of HBsAg loss at end of therapy assessed by measuring HBV s Ag during the period 8,12.24,36 and 48 weeks

  8,12,24 and 48 weeks

• The relationship between HBV genotype and HBsAg loss at the end of the study assessed by measuring HBV genotype only at base line and see if any particular genotype have more HBV sAg loss at the end of the study

  At base line & 48 weeks

Study Arms (2)

PEG-IFN & NUCLEOTIDE ANALOGUES

EXPERIMENTAL

Peginterferon alfa-2a 180 Mcg infusion per week with ongoing NUCLEOTIDE ANALOGUES for 48 weeks.

Drug: PEG-IFN & Nucleos(t)tide analogues; Drug: Nucleos(t)tide analogues

NUCLEOTIDE ANALOGUES

ACTIVE COMPARATOR

Nucleoside same dose as they started the study.

Drug: Nucleos(t)tide analogues

Interventions

PEG-IFN & Nucleos(t)tide analogues DRUG

Subjects who will be randomized to receive 180 Mcg/ week as an add-on Pegylated Interferon therapy α-2 A with their ongoing NUCLEOTIDE analogues for 48 weeks.

Also known as: Immunomodulatory therapy

PEG-IFN & NUCLEOTIDE ANALOGUES

Nucleos(t)tide analogues DRUG

Subjects will continue on the same dose of Nucleoside/nucleotide analogues as they started the study.

Also known as: Nucleoside/nucleotide analogues

NUCLEOTIDE ANALOGUES; PEG-IFN & NUCLEOTIDE ANALOGUES

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 \& \< 70 years of both genders.
• CHB on NA's in maintained viral suppression (HBV DNA PCR \<200 for last 3-6 month)
• Patients with measurable HBsAg quantitative levels
• Patients with any HBV genotypes.
• Patients with either CHB e Ag positive or eAg negative
• Patients with hepatitis Delta co-infection.
• only patients with a negative pregnancy test who are of child bearing potential and agree to utilize a strict birth control method will be enrolled

You may not qualify if:

• Patients with following characteristics will not be considered for the trial:
• Decompensated liver Cirrhosis
• HCV (hepatitis C virus) or HIV co infection.
• Autoimmune disorders like SLE (Systemic lupus erythematosus), RA (Rheumatoid Arthritis ), AIH (Autoimmune Hemolytic Anemia), ITP (Immune thrombocytopenic purpura), psoriasis etc.
• Untreated psychiatric conditions like depression and alcohol or drug abuse.
• Comorbid conditions like chronic renal failure or post renal/liver transplantation on immunosuppressive therapy.
• Complicated diabetes mellitus and advanced heart failure.
• Pregnancy or not willing to practice contraception.
• Known allergy to Interferons.
• Concomitant treatment with Telbivudine
• Evidence of portal hypertension by Biochemical (Low Platelets less than 100), imaging or UGI (upper gastrointestinal)endoscopy

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead
• Hoffmann-La Roche: collaborator

Study Sites (3)

King Abdulaziz Medical City

Jeddah, 22384, Saudi Arabia

RECRUITING

King Abdulaziz Hospital

Jeddah, 31982, Saudi Arabia

RECRUITING

King Abdulaziz Medical City

Riyadh, 11426, Saudi Arabia

RECRUITING

Related Publications (13)

• Goldstein ST, Zhou F, Hadler SC, Bell BP, Mast EE, Margolis HS. A mathematical model to estimate global hepatitis B disease burden and vaccination impact. Int J Epidemiol. 2005 Dec;34(6):1329-39. doi: 10.1093/ije/dyi206. Epub 2005 Oct 25.

  PMID: 16249217 BACKGROUND

• Beasley RP. Hepatitis B virus. The major etiology of hepatocellular carcinoma. Cancer. 1988 May 15;61(10):1942-56. doi: 10.1002/1097-0142(19880515)61:103.0.co;2-j. No abstract available.

  PMID: 2834034 BACKGROUND

• Bosch FX, Ribes J, Cleries R, Diaz M. Epidemiology of hepatocellular carcinoma. Clin Liver Dis. 2005 May;9(2):191-211, v. doi: 10.1016/j.cld.2004.12.009.

  PMID: 15831268 BACKGROUND

• Liaw YF, Chu CM. Hepatitis B virus infection. Lancet. 2009 Feb 14;373(9663):582-92. doi: 10.1016/S0140-6736(09)60207-5.

  PMID: 19217993 BACKGROUND

• Al-Tawfiq JA, Anani A. Profile of viral hepatitis A, B, and C in a Saudi Arabian hospital. Med Sci Monit. 2008 Jan;14(1):CR52-56.

  PMID: 18160946 BACKGROUND

• Memish ZA, Knawy BA, El-Saed A. Incidence trends of viral hepatitis A, B, and C seropositivity over eight years of surveillance in Saudi Arabia. Int J Infect Dis. 2010 Feb;14(2):e115-20. doi: 10.1016/j.ijid.2009.03.027. Epub 2009 Jun 21.

  PMID: 19540786 BACKGROUND

• Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, Huang GT, Iloeje UH; REVEAL-HBV Study Group. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA. 2006 Jan 4;295(1):65-73. doi: 10.1001/jama.295.1.65.

  PMID: 16391218 BACKGROUND

• Chan HL, Tse CH, Mo F, Koh J, Wong VW, Wong GL, Lam Chan S, Yeo W, Sung JJ, Mok TS. High viral load and hepatitis B virus subgenotype ce are associated with increased risk of hepatocellular carcinoma. J Clin Oncol. 2008 Jan 10;26(2):177-82. doi: 10.1200/JCO.2007.13.2043.

  PMID: 18182659 BACKGROUND

• Zoulim F, Locarnini S. Hepatitis B virus resistance to nucleos(t)ide analogues. Gastroenterology. 2009 Nov;137(5):1593-608.e1-2. doi: 10.1053/j.gastro.2009.08.063. Epub 2009 Sep 6.

  PMID: 19737565 BACKGROUND

• Cooksley WG, Piratvisuth T, Lee SD, Mahachai V, Chao YC, Tanwandee T, Chutaputti A, Chang WY, Zahm FE, Pluck N. Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat. 2003 Jul;10(4):298-305. doi: 10.1046/j.1365-2893.2003.00450.x.

  PMID: 12823597 BACKGROUND

• Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology. 2007 Feb;45(2):507-39. doi: 10.1002/hep.21513. No abstract available.

  PMID: 17256718 BACKGROUND

• Liaw YF, Leung N, Kao JH, Piratvisuth T, Gane E, Han KH, Guan R, Lau GK, Locarnini S; Chronic Hepatitis B Guideline Working Party of the Asian-Pacific Association for the Study of the Liver. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatol Int. 2008 Sep;2(3):263-83. doi: 10.1007/s12072-008-9080-3. Epub 2008 May 10.

  PMID: 19669255 BACKGROUND

• Lee A. Prevention of Helicobacter pylori infection. Scand J Gastroenterol Suppl. 1996;215:11-5.

  PMID: 8722377 BACKGROUND

MeSH Terms

Conditions

Hepatitis B

Interventions

Immunomodulation; Nucleosides

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Immune System Phenomena; Glycosides; Carbohydrates; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Abduljaleel Alalwan, MD

  National Guards Health Affairs-Riyadh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abduljaleel Alalwan, MD

CONTACT

801 111; alwana@ngha.med.sa

Ansif Majeed, MBA

CONTACT

(011)429-9999; pallathmajeedan@ngha.med.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2016
• First Posted: December 6, 2016
• Study Start: March 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: March 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (3)