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To Study the Effect of Adding on Pegylated Interferon (PEG-INF) Therapy for Patients Diagnosed With Chronic Hepatitis B (RC14/055)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02982837
Recruitment Status : Unknown
Verified January 2018 by King Abdullah International Medical Research Center.
Recruitment status was:  Recruiting
First Posted : December 6, 2016
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
King Abdullah International Medical Research Center

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).

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: PEG-IFN & Nucleos(t)tide analogues Drug: Nucleos(t)tide analogues Phase 4

Detailed Description:
Hepatitis B virus (HBV) infection remains a global health care problem with more than one third of world's population having serological evidence of been exposed to the virus and about 5% of global population ( 350-400 million) being chronically infected. About 15-40% of Patients with chronic hepatitis B (CHB) infection develop complications of liver cirrhosis, liver failure and hepatocellular carcinoma(HCC) in their life time , resulting in an estimated of 500,000 to 1.2 million deaths each year. In Saudi Arabia, chronic hepatitis B remains a serious medical problem, despite the implementation of mandatory HBV vaccination of children since 1989. According to a recent study conducted in Saudi hospital, HBV accounts for 49% of the hepatitis cases . Persistent viral replication is associated with disease progression to liver fibrosis, cirrhosis and development of HCC. Currently two classes of drugs are available for treatment of CHB namely immunomodulatory therapy (conventional & pegylated interferon (Pegasys) PEG-IFN) and nucleoside/nucleotide analogues(NA). Interferon(IFN)-α with its dual immunomodulatory and antiviral effects was the first drug (recombinant standard IFN- α) licensed for Chronic hepatitis B treatment in the 1990's followed by introduction of nucleos(t)ide analogues(NA) in 1998 that directly inhibit HBV polymerase and provide an effective on treatment maintained viral suppression . With the introduction of pegylated interferon- α (PEG-IFN) in 2005 that allows a convenient once a week dosing interval and of equal or superior treatment efficacy than conventional (IFN), the interferon based therapy has markedly improved its utility. Due to its predominant immunomodulatory effect peginterferon (PEG-IFN) offers the advantage of higher sustained off treatment response rate compared to NA thus allowing a finite duration of treatment. The NA act by directly inhibiting HBV polymerase resulting in effective on treatment maintained viral suppression (HBV DNA PCR <200 for last 3-6 month)). However, long term NA therapy has the problems of emergence of viral resistance, long -term safety, cost and patient compliance.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Multicenter, Open -Label Clinical Trial to Study the Effect of Adding on Pegylated Interferon Therapy for Patients Diagnosed With Chronic Hepatitis B Showing Maintained Response While Receiving Ongoing Nucleotide Analogues
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arm Intervention/treatment
Experimental: PEG-IFN & NUCLEOTIDE ANALOGUES
Peginterferon alfa-2a 180 Mcg infusion per week with ongoing NUCLEOTIDE ANALOGUES for 48 weeks.
Drug: PEG-IFN & Nucleos(t)tide analogues
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.
Other Name: Immunomodulatory therapy

Drug: Nucleos(t)tide analogues
Subjects will continue on the same dose of Nucleoside/nucleotide analogues as they started the study.
Other Name: Nucleoside/nucleotide analogues

Active Comparator: NUCLEOTIDE ANALOGUES
Nucleoside same dose as they started the study.
Drug: Nucleos(t)tide analogues
Subjects will continue on the same dose of Nucleoside/nucleotide analogues as they started the study.
Other Name: Nucleoside/nucleotide analogues




Primary Outcome Measures :
  1. The loss of HbsAg between groups (NA) group and NA +Peg_INF group assessed by HbsAg test [ Time Frame: 48 weeks ]
    The loss of HbsAg between groups (NA) group and NA +Peg_INF group assessed by HbsAg test


Secondary Outcome Measures :
  1. The seroconversion to HBs antibody between groups (NA) group and NA +Peg_INF group assessed by Hbe Ab test [ Time Frame: 6 ,12 months & 48 weeks ]
    The seroconversion to HBs antibody between groups (NA) group and NA +Peg_INF group assessed by Hbe Ab test

  2. 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 [ Time Frame: 6,12 months & 48 weeks ]
    HBeAg loss in CHRONIC HBV eAg positive patient between groups (NA) group and NA +Peg_INF group assessed by HbeAg test

  3. 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 [ Time Frame: 6,12 months & 48 weeks ]
    The conversion of HBeAg to HBe-antibody in CHRONIC HBV eAg positive patient between groups (NA) group and NA +Peg_INF group assessed by HBe-antibody test

  4. 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 [ Time Frame: 8,12,24 and 48 weeks ]
    The correlation between HBsAg 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 that period 8,12.24,36 and 48 weeks

  5. 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 [ Time Frame: At base line & 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

  6. The relationship between IL28B (Interleukin 28B) genotypes ( polymorphism) and HBsAg loss with or without seroconversion to HBs antibody [ Time Frame: At base line & 48 weeks ]
    The relationship between IL28B genotypes ( polymorphism) and HBsAg loss with or without seroconversion to HBs antibody assess by doing IL28B genotypes ( polymorphism) once during the study and see if any specific IL28B genotypes ( polymorphism) associated more with HBV sAg loss at the end of the study with or without seroconversion to HBs antibody).

  7. The relationship between vitamin D deficiency and (HbsAg loss with or without seroconversion to HBs antibody) assess by measuring Vitamin D level at base line And correlate the baseline level of Vitamin with HBV sAg loss at the end of the study [ Time Frame: At base line & 48 weeks ]
    The relationship between vitamin D deficiency and (HbsAg loss with or without seroconversion to HBs antibody) assess by measuring vitamin D level at base line And correlate the base line level of vitamin D with HBV sAg loss at the end of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 who sign an informed consent for inclusion into the study.
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982837


Contacts
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Contact: Abduljaleel Alalwan, MD 801 111 ext 11622 alwana@ngha.med.sa
Contact: Ansif Majeed, MBA (011)429-9999 ext 94436 pallathmajeedan@ngha.med.sa

Locations
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Saudi Arabia
King Abdulaziz Medical City Recruiting
Jeddah, Saudi Arabia, 22384
Contact: Faisal Sanai, MD    +966 12 2266666 ext 24828    sanaifa@ngha.med.sa   
King Abdulaziz Hospital Recruiting
Jeddah, Saudi Arabia, 31982
Contact: Elsadig Ahmed Nour Mohamed, MD       mohamedel1@ngha.med.sa   
King Abdulaziz Medical City Recruiting
Riyadh, Saudi Arabia, 11426
Contact: Abduljaleel Alwan, MD    801 111 ext 11622    alwana@ngha.med.sa   
Contact: Ansif Majeed, MBA    (011)429-9999 ext 94436    pallathmajeedan@ngha.med.sa   
Sponsors and Collaborators
King Abdullah International Medical Research Center
Hoffmann-La Roche
Investigators
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Principal Investigator: Abduljaleel Alalwan, MD National Guards Health Affairs-Riyadh
Publications:

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Responsible Party: King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT02982837    
Other Study ID Numbers: PDU15001
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic