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Chronic Hepatitis CPhase 3NCT00158496

Chronic Hepatitis C Treatment by Pegylated Interferon and Ribavirin in Naive Egyptian Patients (ANRS 1211)

A Phase 3 study testing pegylated interferon alpha2a and ribavirin in people with Chronic Hepatitis C, run by French National Agency for Research on AIDS and Viral Hepatitis at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type of HCV present in Egypt (genotype 4), has the reputation to respond poorly to Interferon treatment at the chronic stage. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis C
What is being tested?
pegylated interferon alpha2a and ribavirin
How many people
100 participants
Where
2 sitesEgypt
Study dates
Aug 2002to Jan 2005
Phase
Phase 3
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HCV antibodies using a third generation test
  • HCV RNA positive by PCR
  • Liver biopsy in the past 18 months with METAVIR score over A2 and over or equal to F1, or over or equal A1 and over F2
  • ALT over 1.5 time the normal range in the 24 weeks prior to inclusion (Week-28; W-2);
  • Patients never treated with ribavirin, IFNalpha or PEG-IFNalpha
  • Normal albumin
Show all 23Show fewer
  • Prothrombin time over or equal to 60 percent
  • Normal bilirubin
  • Alpha-foeto-protein under or equal to 3 times the normal range for the laboratory
  • HBs antigen negative
  • Two negative Kato test (for S.mansoni) three days apart
  • Hemoglobin over or equal 11g/dl,
  • Leucocytes over or equal 3000/mm3
  • Neutrophils over or equal 1500/mm3
  • Platelets over or equal 100 000/mm3
  • Blood creatinin over or equal 150 micromol/l
  • Normal TSH
  • Anti-nuclear antibodies under 1/160
  • Fasting blood sugar between 70-115mg/dl (if glucose intolerance or diabetes: HbA1C <= 8,5%)
  • Normal ophthalmologic examination in patients with history of blood pressure and/or diabetes
  • Effective contraception during the treatment period
  • No breastfeeding during the study period.
  • Signed informed consent

Who cannot join

  • Co-infection with hepatitis B (positive HBs antigen)
  • Hemochromatosis
  • Alpha-1 anti-trypsin deficiency
  • Wilson disease
  • Alcoholism-related liver disease
  • Gilbert disease
Show all 18Show fewer
  • Alcohol intake over 50g/day for males and 40 g/day for females
  • Ongoing intravenous drug use
  • Aggravated liver cirrhosis (history or presence of ascitis, oesophageal varicosis, liver encephalopathy)
  • Hepatocellular carcinoma
  • Psychiatric disease: history of severe nervous breakdown or severe psychiatric diseases such as major psychosis, suicidal ideas, suicide attempts…
  • Epilepsy
  • Auto-immune disease
  • Heart disease in the six months preceding enrolment - patients with significant changes at EKG
  • Uncontrolled diabetes
  • Chronic respiratory insufficiency with hypoxemia <10 kPa
  • Medical or surgical condition, non-stabilised, with life expectancy lower than two years.
  • Pregnancy or breastfeeding

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • National Hepatology and Tropical Medicine Research Institute

    Cairo

  • Ismail Sallam hospital

    Zawiat Razin, Menoufia

Other trials in Egypt

About this study

Official title: Clinical Trial of the Efficacy of the Combination of Pegylated Interferon (PEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C

Chronic hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type of HCV present in Egypt (genotype 4), has the reputation to respond poorly to Interferon treatment at the chronic stage. Pegylated Interferon is a new form of Interferon that stays in the body for longer time and allows the patient to take less injection per week. It has proved to be more effective than standard Interferon. The combination of two drugs, Interferon and Ribavirin, is considered to be the best treatment available for chronic hepatitis C.

Read the detailed description

Egypt is the country with the highest HCV prevalence worldwide, and the number of infected Egyptians is estimated around 8 million. The HCV genotype circulating in Egypt is genotype 4. This genotype has the reputation, based on the few available data, to respond poorly to treatment. This study will estimate the safety and efficacy of the combination of peg-IFNα-2a plus Ribavirin, in Egyptian patients with chronic hepatitis C. This treatment has been chosen based on its better expected efficacy compared to pegylated interferon alone.

The primary objective of the study is to assess the efficacy and tolerance of the combination of pegylated interferon (peg-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for HCV.

Methods: Open trial. Follow-up duration: 72 weeks. Enrolment duration: 18 months. Total trial duration: 3 years and a half, including trial analysis (carried out in the 6 months following the follow-up completion of the last patient). Total number of patients: 100. Precision around the expected efficacy rate (40% in intention-to-treat analysis): 9.6%.

Treatment strategy: Peg-IFNα-2a 180microg/week for 48 weeks, Ribavirin at least 11 mg/kg/day for 48 weeks Main inclusion criteria: HCV RNA positive by PCR; METAVIR score : >A2 and >= F1 or >= A1 and > F2; ALAT over 1.5*N; no prior treatment with IFNalpha, PEG-IFNalpha and ribavirin Main exclusion criteria : Liver disease other than hepatitis C; advanced liver disease; negative HCV RNA.

Patient from a cohort follow-up conducted in a village in rural Egypt with High HCV prevalence (Menoufia governorate) will be proposed to participate in the trial. Pre-enrolment investigations, liver biopsy, and patients follow-up will be carried out at a local hospital. Blood test analyses will be carried out under the responsibility of Hepatitis Virology Reference Laboratory at the National Hepatology and Tropical Medicine Institute, Cairo; trial monitoring will be carried out by the Department of Community Medicine of Ain Shams; methodological assistance from the "Unite des Maladies Emergentes" at Pasteur Institute and INSERM U444, Paris.

Treatment for patients with HCV RNA by qualitative PCR still positive after 24 weeks of the combination Peg-IFNα-2a with ribavirin, will be stopped.

Being tested
pegylated interferon alpha2a, ribavirin
Keywords
Chronic Hepatitis C, Genotype 4, Pegylated Interferon, Ribavirin, Egypt
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.

  • pegylated interferon alpha2aDrug

  • ribavirinDrug

What is being measured

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

  1. - Disappearance of HCV RNA by qualitative PCR 24 weeks after the end of treatment

Secondary outcomes (5)

  1. Evaluation of HCV RNA at 12 and 24 weeks

  2. changes in HCV RNA load during treatment

  3. Normalization of ALT during treatment and 24 weeks after the end of treatment

  4. Study of side effects

  5. Histological changes 24 weeks after the end of treatment (decrease by at least 1 point of the Metavir score)

Timeline

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

  1. First posted12 Sep 2005 (estimated)
  2. Study startAug 2002
  3. Study completionJan 2005

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00158496
Sponsor's protocol ID
ANRS 1211
Status last verified
Apr 2007
First submitted
8 Sep 2005
Last updated
24 Apr 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • Marzouk D, Sass J, Bakr I, El Hosseiny M, Abdel-Hamid M, Rekacewicz C, Chaturvedi N, Mohamed MK, Fontanet A. Metabolic and cardiovascular risk profiles and hepatitis C virus infection in rural Egypt. Gut. 2007 Aug;56(8):1105-10. doi: 10.1136/gut.2006.091983. Epub 2006 Sep 6.

    PubMed 16956918

  • Mohamed MK, Bakr I, El-Hoseiny M, Arafa N, Hassan A, Ismail S, Anwar M, Attala M, Rekacewicz C, Zalata K, Abdel-Hamid M, Esmat G, Fontanet A. HCV-related morbidity in a rural community of Egypt. J Med Virol. 2006 Sep;78(9):1185-9. doi: 10.1002/jmv.20679.

    PubMed 16847958

  • Bakr I, Rekacewicz C, El Hosseiny M, Ismail S, El Daly M, El-Kafrawy S, Esmat G, Hamid MA, Mohamed MK, Fontanet A. Higher clearance of hepatitis C virus infection in females compared with males. Gut. 2006 Aug;55(8):1183-7. doi: 10.1136/gut.2005.078147. Epub 2006 Jan 24.

    PubMed 16434426

  • Arafa N, El Hoseiny M, Rekacewicz C, Bakr I, El-Kafrawy S, El Daly M, Aoun S, Marzouk D, Mohamed MK, Fontanet A. Changing pattern of hepatitis C virus spread in rural areas of Egypt. J Hepatol. 2005 Sep;43(3):418-24. doi: 10.1016/j.jhep.2005.03.021.

    PubMed 16019104

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pegylated interferon alpha2a and ribavirin in people with Chronic Hepatitis C, run by French National Agency for Research on AIDS and Viral Hepatitis at 2 sites 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 23 inclusion and 18 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: finished, as of the sponsor's last update on 24 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

- Disappearance of HCV RNA by qualitative PCR 24 weeks after the end 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 NCT00158496, which also lists 4 linked publications.

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 24 Apr 2007.

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