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Chronic Hepatitis cPhase 4QuadritherapyNCT01896609

Trial Comparing the Efficacy, Tolerability and Safety Between Three Arms in Treatment of HCV in Egyptian Population

A Phase 4 study testing Reiferon Retard in Arm 1, Bon one in Arm 3 and Xerovirinc in Arm 2 in people with Chronic Hepatitis c, run by MinaPharm Pharmaceuticals at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A single Center, Prospective Phase IV, Open-Label, Controlled, Randomized Trial comparing the efficacy, safety, and tolerability of Quadritherapy regimen (Reiferon Retard® , Ribavirin , Nitazoxanide and Alfacalcidol (Bon-One ® ) versus Triple therapy regimen (Reiferon Retard® , Ribavirin and Nitazoxanide) versus the… Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Chronic Hepatitis c
What is being tested?
Reiferon Retard in Arm 1, Bon one in Arm 3 and Xerovirinc in Arm 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteEgypt
Study dates
Jun 2013to Jun 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The subject signs and dates a written informed consent form (ICF) prior to any study-related activities, including discontinuation of any prohibited medications.
  • If the subject is male and sexually active, he is eligible to enter and participate in this study if his partner(s) meet the criteria outlined in 2a or if he or his partner(s) are using one of the methods of birth control outlined in 2b. If the subject is female, she is eligible to enter and participate in this study if she meets the following criteria:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is postmenopausal; for purposes of this study, postmenopausal is defined as 1 year without menses); or
  • Childbearing potential, has a negative serum pregnancy test at screening.
  • The subject is between the ages of 20 and 50, inclusive at the time of the screening visit.
  • The subject is an ambulatory outpatient. Ambulatory is defined as not depending exclusively on a wheelchair for mobility. Nursing home subjects may be enrolled provided they are ambulatory. Subjects with spinal cord injuries resulting in paraplegia may not be enrolled.
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  • The subject is or has been diagnosed with Hepatitis C genotype 4.
  • Subjects are treatment Naive
  • Male or female subjects with BMI ≤ 35 .
  • Compensated liver disease with all the following minimum hematological and biochemical criteria:
  • Hemoglobin > 12 g/dl for males, >11 g/dl for females.
  • White blood cell count (WBC) > 3,000 /mm3 - Absolute Neutrophilic count (ANC above 1000)
  • Platelets > 80,000/mm3
  • Prothrombin time less than 4 seconds above the upper limit of normal (ULN).
  • Serum albumin > 3.5mg/dl
  • Normal Bilirubin level (except for Gilbert's syndrome where indirect Bilirubin should be < 3mg/dl)
  • Histological diagnosis of chronic hepatitis with Fibroscan( fibrosis assessment).
  • Normal fasting blood glucose level or within 20% of ULN for non-diabetic patients. If there is a history of diabetes, hemoglobin A1C <8.5% (as evidence of good glucose control in recent months).
  • Serum Creatinine within normal limits.
  • Thyroid Stimulating Hormone (TSH) within normal limits of testing lab. Patients requiring medications to maintain TSH are eligible if they have fulfilled all other inclusion and exclusion criteria.
  • Alpha Fetoprotein within normal range obtained during one year prior to entry in the study. Results above the upper limit of normal but less than 100 units require both of the following:
  • Alpha Fetoprotein obtained within 3 months of entry.
  • Abdominal Ultrasound within 3 months of entry that is negative for evidence of hepatocellular carcinoma.
  • If Alpha Fetoprotein is above 100 units CT scan of the abdomen that is negative for evidence of hepatocellular carcinoma is required.
  • Patients must be serum hepatitis B surface antigen (HBsAg) negative.
  • Negative Antinuclear Antibodies (ANA) or titer of < 1:160
  • Serum positive for anti-HCV antibodies and HCV-RNA.
  • Abdominal Ultrasound obtained within one year prior to entry in the study
  • Electrocardiogram for men aged > 40 years.
  • Normal urine analysis.
  • Normal fundus exam.
  • Serum Schistosoma antibody test, if positive > 1/80, a rectal biopsy is required. If rectal biopsy is positive to living Schistosomal eggs, treatment of Active Schistosomal disease is required one month prior to enrollment.

Who cannot join

  • The subject has been diagnosed with HBV or HCV of any genotype other than genotype 4 and /or HIV.
  • Subjects are older than 50 years or younger than 20 years of age.
  • Women who are pregnant or breast-feeding.
  • Suspected hypersensitivity to Interferon or Ribavirin.
  • Subjects with organ transplant other than corneal or hair transplant.
  • Any cause of the liver disease based on the patient's history and biopsy other than chronic hepatitis C genotype 4, including but not limited to:
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  • Alpha 1-antitrypsin deficiency.
  • Wilson's disease.
  • Liver transplant patients.
  • Autoimmune hepatitis.
  • Alcoholic liver disease.
  • Obesity induced disease.
  • Drug related liver disease.
  • Co-infection with Hepatitis B Virus (HBV) or HIV (HBsAg or HIV antibodies positivity).
  • Hemochromatosis (iron deposition more than 2+ in liver parenchyma)
  • Evidence of advanced liver disease such as history or presence of ascitis, bleeding varices, spontaneous encephalopathy.
  • In the opinion of the investigator, the subject has a concurrent illness or disability (excluding HCV genotype 4) that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study ;
  • Unstable pulmonary, endocrine \& metabolic disorders e.g. poorly controlled diabetes.
  • Subjects with hemophilia or any hemoglobinopathy including but not limited to thalassemia major or minor.
  • Bone marrow compromise contraindicated for interferon treatment
  • Central Nervous System (CNS) trauma or active seizures that require medications.
  • The subject exhibits renal impairment as evidenced by a serum Creatinine higher than 2.0 mg/dL. Or history of Chronic renal failure
  • Immunologically mediated diseases (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythromatosis, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia)
  • Any medical condition requiring or likely to require during course of the study, chronic systemic administration of steroids.
  • Patients with clinically significant retinal abnormalities.
  • The subject has a history of unstable or deteriorating cardiac disease within the previous 6 months, including, but not limited to, the following:
  • Myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, or coronary angioplasty ii. Congestive heart failure requiring hospitalization iii. Uncontrolled arrhythmias
  • The subject has been diagnosed with a major psychiatric disorder (e.g., major depression or psychoses) within the past 2 years that required hospitalization and/or involved an attempted suicide. Subjects diagnosed with a major psychiatric disorder that did not require hospitalization or involve an attempted suicide must have remained on a stable dose of medication for at least 6 months prior to the screening visit.
  • The subject has a history of alcohol or substance abuse within the past 2 years.
  • The subject has a positive stool sample for ova or parasite (exception: the finding of Entamoeba coli is not exclusionary).
  • The subject has any evidence or treatment of malignancy (other than localized basal cell cancer, squamous cell skin cancer, or cancer in situ that has been resected) within the previous 5 years.
  • The subject used an investigational drug or participated in an investigational study within 30 days of screening.
  • The subject refuses to discontinue one (or more) prohibited medications at least 7 days prior to the screening visit.
  • The subject refuses to maintain a stable dose of one (or more) allowable concurrent medications for at least 30 days prior to the screening visit.
  • The subject is unable or unwilling to follow directions.
  • Contraindications to ribavirin and thus combination therapy include marked anemia, renal dysfunction, and coronary artery or cerebrovascular disease, and inability to practice birth control.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting

  • Faculty of Medicine , Cairo University

    Cairo, Cairo Governorate

    Rasha Ahmed, MD, +201063432400, rasha7019@yahoo.com

    Moustafa Sameer, +201006016212, msameer@minapharm.com

    Recruiting

Other trials in Egypt

About this study

Official title: A Single Center, Prospective Phase IV, Open-Label, Randomized Trial Comparing the Efficacy , Tolerability, and Safety of Quadritherapy Regimen (Reiferon Retard® + Ribavirin + Nitazoxanide + Alfacalcidol ( Bon-One ®) ) Versus Triple Therapy Regimen (Reiferon Retard® + Ribavirin + Nitazoxanide) Versus the Standard of Care Regimen(Reiferon Retard® + Ribavirin) in the Treatment of Naïve Chronic Hepatitis- C Among the Egyptian Population. Effectiveness Will be Evaluated Based on Sustained Viral Response (SVR)

A single Center, Prospective Phase IV, Open-Label, Controlled, Randomized Trial comparing the efficacy, safety, and tolerability of Quadritherapy regimen (Reiferon Retard® , Ribavirin , Nitazoxanide and Alfacalcidol (Bon-One ® ) versus Triple therapy regimen (Reiferon Retard® , Ribavirin and Nitazoxanide) versus the standard of care regimen(Reiferon Retard® and Ribavirin) in the treatment of Naïve chronic hepatitis C among the Egyptian population. Effectiveness will be evaluated based on Sustained Virological Response (SVR) .

PRIMARY OBJECTIVE(S): The primary objectives of this trial are as follows:

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  • To compare the efficacy of the three treatment arms in naïve Chronic Hepatitis C Virus (HCV) genotype 4 patients by evaluating the sustained virological response ( SVR) at week 60 ( 3 months after end of treatment period)
  • Identify optimum treatment protocol for HCV genotype 4 in respect to used combination of medications
  • Whether adding vitamin D, a potent immunomodulator, could improve viral response.

STUDY DESIGN: This is a phase IV, single center, open labeled, randomized (1:1:1) controlled study.

NUMBER OF EVALUABLE SUBJECTS: 300 NUMBER OF CENTER/S: 1 Country:Egypt DURATION OF THE STUDY: 94 weeks TREATMENT: randomized 1:1:1 ratio into 3 Arms SUBJECT POPULATION: male or female subjects assessed by BMI less than 35, between the ages of 20 and 50 years. Subjects have to be diagnosed as Naïve Chronic Hepatitis C genotype 4 patients with compensated liver disease assessed by hematological and biochemical tests.

  • DURATION OF THE STUDY: 94 weeks as follows:

Estimated Enrollment Duration: 16 weeks Collection of last Case Report Form (CRF) : 2 weeks from Last patient out. Queries Resolution: 4 weeks from Collection of last CRF. Database lock planned date: 2 weeks from Quires resolution. Final Study Report: 8 weeks from Database lock. Estimated duration of subject participation: 62 weeks as follows;

  • Screening period per subject = 2 weeks
  • Treatment phase per subject = 48 weeks
  • Follow-up phase per subject = 12 weeks

N.B : Each patient will receive medications for Maximum 48 weeks if his/her Polymerase Chain Reaction (PCR) -ve at weeks 12 and 24 , and if his/her PCR +ve at week 12 or week 24 the treatment will be stopped .

Being tested
Reiferon Retard in Arm 1, Bon one in Arm 3, Xerovirinc in Arm 2, Ribavirin in Arm 1
Keywords
Chronic hepatitis c, Egyptian population, Reiferon Retard, Ribavirin, Nitazoxanide, Bon one
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reiferon Retard in Arm 1Biological

    Also called Pegylated interferon alfa-2a (Reiferon Retard 160 µg ®)

    Arm 1,2,3 Reiferon Retard® 160 µg /week subcutaneous injection for 48 weeks

  • Bon one in Arm 3Drug

    Arm 3 , Bon One ® 0.5 µg daily orally for 48 weeks

  • Xerovirinc in Arm 2Drug

    Also called Nitazoxanide

    Arm 2,3 Xerovirinc® 500mg twice daily orally for 48 weeks

  • Ribavirin in Arm 1Drug

    Arm 1,2,3 Ribavirin in a dose of 13 mg/kg/day orally for 48 weeks

Study groups in NCT01896609
Study groupRoleWhat they receive
Arm 1 (Standard therpy)ExperimentalArm 1 : subject randomized to this arm will be receiving the standard care therapy for 48 weeks: * Reiferon Retard® 160 µg /week subcutaneous injection. * Ribavirin in a dose of 13 mg/kg/day orally
Receives: Biological: Reiferon Retard in Arm 1; Drug: Ribavirin in Arm 1
Arm 2 ( Xerovirinc)ExperimentalArm 2 : Subjects randomized to this arm will be receiving the following medications for 48 weeks; * Reiferon Retard® 160 µg /week subcutaneous injection * Ribavirin in a dose of 13 mg/kg/day orally * Xerovirinc® 500mg twice daily orally.
Receives: Biological: Reiferon Retard in Arm 1; Drug: Xerovirinc in Arm 2; Drug: Ribavirin in Arm 1
Arm 3 ( Bon one )ExperimentalArm 3: Subjects randomized to this arm will be receiving the following medications for 48 weeks: * Bon-One ® 0.5 µg daily orally * Reiferon Retard® 160 µg /week subcutaneous injection * Ribavirin in a dose of 13 mg/kg/day orally * Xerovirinc® 500mg twice daily orally.
Receives: Biological: Reiferon Retard in Arm 1; Drug: Bon one in Arm 3; Drug: Xerovirinc in Arm 2; Drug: Ribavirin in Arm 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early virological response

    Early Virological Response (EVR) achieved by undetected Hepatitis C Virus (HCV) RNA after 12 weeks ( 3 months after start of treatment)

    Measured: 3 months after start of treatment

Secondary outcomes (1)

  1. Sustained Virological Response ( SVR )

    Sustained Virological Response ( SVR ) achieved by undetected HCV RNA after 1 year and 12 weeks (3 months after end of treatment) .

    Measured: 3 months after end of treatmet ( Week 60)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJan 2015 (estimated)
  4. Study completionJun 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01896609
Sponsor's protocol ID
HCV05012012
Acronym
Quadritherapy
Status last verified
Jul 2013
First submitted
19 Jun 2013
Last updated
11 Jul 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Reiferon Retard in Arm 1, Bon one in Arm 3 and Xerovirinc in Arm 2 in people with Chronic Hepatitis c, run by MinaPharm Pharmaceuticals at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early virological response (time frame: 3 months after start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01896609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.

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