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Chronic Hepatitis cPhase 3NCT03163849

Assessment Effects After Direct Acting Antiviral in Chronic Hepatitis c Virus Patients

A Phase 3 study testing Sofosbuvir , daclatasvir in people with Chronic Hepatitis c, run by Assiut University at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Chronic hepatitis C virus infection affects an estimated one hundred and seventy million people around the world with and approximate prevalence 0.2-2 % in the United State of America and European countries. 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?
Sofosbuvir , daclatasvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
2 sitesEgypt
Study dates
1 Sep 2019to 30 Jul 2020
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

  • Our study proposed for all consented patients complaining from chronic Hepatitis C virus infection undergoing treatment with antiviral drugs is possible through certain indications or criteria as follow:
  • Patients with chronic Hepatitis C virus who are candidates for Direct Acting Antiviral Therapy:
  • Age is from 18 to 65 years.

Who cannot join

  • Those patients with chronic Hepatitis C virus infection are impossible or contraindicated to be treated with antiviral drugs as follow: - Geriatrics (> 65 years of age): - Pediatrics (< 18 years of age): - patients with known hypersensitivity to any of the components of the antiviral drug.
  • Post-Liver Transplant Patients. ـPatients with primary haematological abnormalities not related to chronic hepatitis C virus infection
  • Experienced patients (previously failed treatment)

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • Assuit

    Asyut, Assuit

  • Assuit

    Asyut

Other trials in Egypt

About this study

Official title: Assessment of Haematological and Biochemical Effect After New Direct Acting Antiviral Drugs in Chronic Hepatitis c Virus Egyptian Patients in Assiut Province

Chronic hepatitis C virus infection affects an estimated one hundred and seventy million people around the world with and approximate prevalence 0.2-2 % in the United State of America and European countries.

Read the detailed description

In Egypt, Chronic hepatitis C virus is a serious health problem where Chronic hepatitis C virus prevalence is very high.

Chronic Chronic hepatitis C virus infection is associated with a high risk for liver-related mortality because of a variety of complications, which appear obviously in those patients with developing end-stage liver disease, including decompensated liver cirrhosis and hepatocellular carcinoma. Egypt had the highest burden of deaths from Chronic hepatitis C virus-associated hepatocellular carcinoma in the Arab world, around sixty three percentage of all Chronic hepatitis C virus-associated hepatocellular carcinoma deaths happened in Egypt.

Poor response rates and poor tolerability were observed during treatment of chronic Chronic hepatitis C virus infection with pegylated interferon and ribavirin.

Because Chronic hepatitis C virus does not incorporate into the human genome and must replicate to maintain infection, it should be potential to destroy the virus completely by blocking replication at one or more stages of the life cycle.

In recent years, there has been a shift in treatment paradigm with the discovery and approval of agents that target specific proteins vital for hepatitis C replication. The Non Structural 3/4A inhibitors simeprevir and paritaprevir, the NonStructural 5A inhibitors ombitasvir, ledipasvir, and daclatasvir, and the Non Structural 5B inhibitors sofosbuvir and dasabuvir have been approved and incorporated as first-line agents into the latest guidelines for Hepatitis C treatment. Used in combination, these agents produce higher rates of sustained virologic response and less adverse effects than historical options, along with limited rates of resistance.

In previous studies ,haematological side effect of interferon and Ribavirin was reported in the form of reduction in Haemoglobin ,White Blood Cells and asymptomatic thrombocytopenia While SOF based combination therapy improved the liver function, anemia ,leucopenia and thrombocytopenia were detected especially after treatment with SOF,RBV and PegINF alpha .also significant improvement in the level of ALT and AST post treatment with either SOF and RBV or SOF ,RBV and INF were detected as compaired to baseline While no significant differences were detected on the level of total bilirubin or creatinine In our study we will assess and evaluate many biochemical and hematological findings upon new direct acting antiviral agents in Egyptian chronic hepatitis C virus patients

Being tested
Sofosbuvir , daclatasvir, Placebos
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.

  • Sofosbuvir , daclatasvirDrug

    Tablets

  • PlacebosDrug

    oral tablets

Study groups in NCT03163849
Study groupRoleWhat they receive
control groupPlacebo comparatororal tablets
Receives: Drug: Placebos
Study groupExperimentalsofosbuvir , daclatasvir oral tablets
Receives: Drug: Sofosbuvir , daclatasvir

What is being measured

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

  1. the percentage of patients with hematological changes

    complete blood count and prothrombin time and concentration

    Measured: 12 weeks

  2. The percentage of patients with antibodies against RBCs

    Coomb's test

    Measured: Pre treatment

Secondary outcomes (2)

  1. the percentage of patients with biochemical changes

    Urea, creatinine,bilirubin,ALT,AST

    Measured: 12 weeks

  2. The percentage of patients with antibodies against RBCs

    Coomb's test

    Measured: Three months after the end of treatment

Timeline

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

  1. First posted23 May 2017
  2. Study start1 Sep 2019
  3. Primary completion1 Jun 2020 (estimated)
  4. Study completion30 Jul 2020 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03163849
Sponsor's protocol ID
PRHCV
Status last verified
Sep 2019
First submitted
18 May 2017
Last updated
12 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Esteban JI, Sauleda S, Quer J. The changing epidemiology of hepatitis C virus infection in Europe. J Hepatol. 2008 Jan;48(1):148-62. doi: 10.1016/j.jhep.2007.07.033. Epub 2007 Nov 5.

    PubMed 18022726

  • Lavanchy D. The global burden of hepatitis C. Liver Int. 2009 Jan;29 Suppl 1:74-81. doi: 10.1111/j.1478-3231.2008.01934.x.

    PubMed 19207969

  • Darwish NM, Abbas MO, Abdelfattah FM, Darwish MA. Hepatitis C virus infection in blood donors in Egypt. J Egypt Public Health Assoc. 1992;67(3-4):223-36.

    PubMed 1296960

  • Fallahian F, Najafi A. Epidemiology of hepatitis C in the Middle East. Saudi J Kidney Dis Transpl. 2011 Jan;22(1):1-9.

    PubMed 21196607

  • El-Serag HB, Mason AC. Rising incidence of hepatocellular carcinoma in the United States. N Engl J Med. 1999 Mar 11;340(10):745-50. doi: 10.1056/NEJM199903113401001.

    PubMed 10072408

  • Davis GL, Albright JE, Cook SF, Rosenberg DM. Projecting future complications of chronic hepatitis C in the United States. Liver Transpl. 2003 Apr;9(4):331-8. doi: 10.1053/jlts.2003.50073.

    PubMed 12682882

  • Verna EC, Brown RS Jr. Hepatitis C virus and liver transplantation. Clin Liver Dis. 2006 Nov;10(4):919-40. doi: 10.1016/j.cld.2006.08.012.

    PubMed 17164125

  • Khan G, Hashim MJ. Burden of virus-associated liver cancer in the Arab world, 1990-2010. Asian Pac J Cancer Prev. 2015;16(1):265-70. doi: 10.7314/apjcp.2015.16.1.265.

    PubMed 25640363

  • Operskalski EA, Kovacs A. HIV/HCV co-infection: pathogenesis, clinical complications, treatment, and new therapeutic technologies. Curr HIV/AIDS Rep. 2011 Mar;8(1):12-22. doi: 10.1007/s11904-010-0071-3.

    PubMed 21221855

  • Chayama K, Hayes CN. HCV Drug Resistance Challenges in Japan: The Role of Pre-Existing Variants and Emerging Resistant Strains in Direct Acting Antiviral Therapy. Viruses. 2015 Oct 13;7(10):5328-42. doi: 10.3390/v7102876.

    PubMed 26473914

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sofosbuvir , daclatasvir in people with Chronic Hepatitis c, run by Assiut University 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 3 inclusion and 3 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 12 Sep 2019. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

the percentage of patients with hematological changes (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT03163849, which also lists 10 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 12 Sep 2019.

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