Liver CirrhosesNCT03283176
Hematologic Profile, Vit. B12 and Folic Acid in Cirrhotics Received Sofosbuvir and Daclatasvir With or Without Ribavirin
An observational study of Liver Cirrhoses and Chronic Hepatitis c, run by Assiut University at 1 site in Egypt.
Trial summary
Use of Ribavirin could affect hematologic profile of the patients negatively. With advent of new antiviral therapy, the preexisting hematologic changes may alter or corrected after treatment. However, this point is still not properly studied. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhoses, Chronic Hepatitis c, Directly Acting Antivirals
- What is being tested?
- Vitamin B12 and Folic Acid
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 14 Jan 2020
- Phase
- Observational
- 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 70 years
- All sexes
- Adult, Older adult
Study population: Fifty patients were diagnosed to have HCV-related liver cirrhosis and candidate for anti- HCV therapy
Who may be able to join
- Patients known to have HCV-related liver cirrhosis and candidate for therapy with Sofosbuvir and Daclatasvir with or without Ribavirin
Who cannot join
- Chronic hepatitis due causes other than chronic HCV infection
- Coinfection with HIV or HBV infection
- Hepatocellular carcinoma
- Decompensated cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Hematologic Profile, Vitamin B12 and Folic Acid Level in Cirrhotic Patients Received Sofosbuvir and Daclatasvir With or Without Ribavirin
Use of Ribavirin could affect hematologic profile of the patients negatively. With advent of new antiviral therapy, the preexisting hematologic changes may alter or corrected after treatment. However, this point is still not properly studied.
Read the detailed description
Hepatitis C virus (HCV) infection is a global health problem that affects 170 million people worldwide, and approximately 55% (95 million) of the infected population is in South East Asia and Western Pacific countries.
Hepatitis C virus (HCV) is considered one of the main causes of chronic hepatitis and also may be complicated by serious complications as liver cirrhosis, ascites and hepatocellular carcinoma. It is also, one of the leading indications for liver transplantation (LT) in adults around the world.
Abnormalities in hematological parameters are common in patients with cirrhosis. The pathogenesis of abnormal hematological indices (HIs) in cirrhosis is multifactorial and includes portal hypertension-induced sequestration, alterations in bone marrow stimulating factors, viral- and toxin-induced bone marrow suppression and consumption or loss. Abnormalities in HIs are associated with an increased risk of complications including bleeding and infection.
So, early recognition and early treatment of those patients with chronic HCV infection can modify its natural history. There are many factors affecting the outcome of HCV infection as viral, environmental and host factors, including immunologic and genetic susceptibilities.
Till 2011, the main lines of therapy were Interferon plus ribavirin for at least 48 weeks but these combinations was associated with low incidence of Sustained Virological Response (SVR). Now, there is era of Direct Acting Analogues that used for treatment of patients with chronic HCV infection and associated with high rate of SVR.
Daclatasvir is a first-in-class HCV NS5A replication complex inhibitor, and Sofosbuvir is a nucleotide analogue HCV NS5B polymerase inhibitor. Both have potent antiviral activity and broad genotypic coverage and are administered orally once daily.
- Being tested
- Vitamin B12 and Folic Acid
- 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.
Vitamin B12 and Folic AcidDiagnostic test
Vitamin B12 and Folic Acid measurement by ELISA technique
| Study group | Role | What they receive |
|---|---|---|
| Sofo-Dacla with Ribavirin | Chronic Hepatitis C related Liver Cirrhosis patients who will take sofosbuveir, Daclatasvir with Ribavirin Receives: Diagnostic Test: Vitamin B12 and Folic Acid | |
| Sofo-Dacla without Ribavirin | Chronic Hepatitis C related Liver Cirrhosis patients who will take sofosbuveir, Daclatasvir without Ribavirin Receives: Diagnostic Test: Vitamin B12 and Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin B12
By ELISA Technique, in Pg/ml
Measured: 1 year
Folic Acid
By ELISA technique, in Pg/ml
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start1 Mar 2018
- Primary completion1 Mar 2019
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Shaaban Redwan Helal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283176
- Sponsor's protocol ID
- Haematological Prof. in DAAs
- Status last verified
- Oct 2020
- First submitted
- 12 Sep 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. doi: 10.1002/hep.22759. No abstract available.
PubMed 19330875Promrat K, McDermott DH, Gonzalez CM, Kleiner DE, Koziol DE, Lessie M, Merrell M, Soza A, Heller T, Ghany M, Park Y, Alter HJ, Hoofnagle JH, Murphy PM, Liang TJ. Associations of chemokine system polymorphisms with clinical outcomes and treatment responses of chronic hepatitis C. Gastroenterology. 2003 Feb;124(2):352-60. doi: 10.1053/gast.2003.50061.
PubMed 12557141Lam AM, Espiritu C, Bansal S, Micolochick Steuer HM, Niu C, Zennou V, Keilman M, Zhu Y, Lan S, Otto MJ, Furman PA. Genotype and subtype profiling of PSI-7977 as a nucleotide inhibitor of hepatitis C virus. Antimicrob Agents Chemother. 2012 Jun;56(6):3359-68. doi: 10.1128/AAC.00054-12. Epub 2012 Mar 19.
PubMed 22430955Ampuero J, Romero-Gomez M, Reddy KR. Review article: HCV genotype 3 - the new treatment challenge. Aliment Pharmacol Ther. 2014 Apr;39(7):686-98. doi: 10.1111/apt.12646.
PubMed 24612116Qamar AA, Grace ND. Abnormal hematological indices in cirrhosis. Can J Gastroenterol. 2009 Jun;23(6):441-5. doi: 10.1155/2009/591317.
PubMed 19543577
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Hematologic Profile, Vitamin B12 and Folic Acid Level in Cirrhotic Patients Received Sofosbuvir and Daclatasvir With or Without Ribavirin
- ClinicalTrials.gov ID
- NCT03283176
- Acronym / sponsor ID
- Haematological Prof. in DAAs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of Ribavirin could affect hematologic profile of the patients negatively. With advent of new antiviral therapy, the preexisting hematologic changes may alter or corrected after treatment. However, this point is still not properly studied.
Detailed description
Hepatitis C virus (HCV) infection is a global health problem that affects 170 million people worldwide, and approximately 55% (95 million) of the infected population is in South East Asia and Western Pacific countries.
Hepatitis C virus (HCV) is considered one of the main causes of chronic hepatitis and also may be complicated by serious complications as liver cirrhosis, ascites and hepatocellular carcinoma. It is also, one of the leading indications for liver transplantation (LT) in adults around the world.
Abnormalities in hematological parameters are common in patients with cirrhosis. The pathogenesis of abnormal hematological indices (HIs) in cirrhosis is multifactorial and includes portal hypertension-induced sequestration, alterations in bone marrow stimulating factors, viral- and toxin-induced bone marrow suppression and consumption or loss. Abnormalities in HIs are associated with an increased risk of complications including bleeding and infection.
So, early recognition and early treatment of those patients with chronic HCV infection can modify its natural history. There are many factors affecting the outcome of HCV infection as viral, environmental and host factors, including immunologic and genetic susceptibilities.
Till 2011, the main lines of therapy were Interferon plus ribavirin for at least 48 weeks but these combinations was associated with low incidence of Sustained Virological Response (SVR). Now, there is era of Direct Acting Analogues that used for treatment of patients with chronic HCV infection and associated with high rate of SVR.
Daclatasvir is a first-in-class HCV NS5A replication complex inhibitor, and Sofosbuvir is a nucleotide analogue HCV NS5B polymerase inhibitor. Both have potent antiviral activity and broad genotypic coverage and are administered orally once daily.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sofo-Dacla with Ribavirin | – | Diagnostic Test: Vitamin B12 and Folic AcidChronic Hepatitis C related Liver Cirrhosis patients who will take sofosbuveir, Daclatasvir with Ribavirin |
| Sofo-Dacla without Ribavirin | – | Diagnostic Test: Vitamin B12 and Folic AcidChronic Hepatitis C related Liver Cirrhosis patients who will take sofosbuveir, Daclatasvir without Ribavirin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Fifty patients were diagnosed to have HCV-related liver cirrhosis and candidate for anti- HCV therapy
Key inclusion criteria (1 listed)
- Patients known to have HCV-related liver cirrhosis and candidate for therapy with Sofosbuvir and Daclatasvir with or without Ribavirin
Key exclusion criteria (4 listed)
- Chronic hepatitis due causes other than chronic HCV infection
- Coinfection with HIV or HBV infection
- Hepatocellular carcinoma
- Decompensated cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B12 and Folic AcidVitamin B12 and Folic Acid measurement by ELISA technique | Diagnostic test | Sofo-Dacla with Ribavirin, Sofo-Dacla without Ribavirin |
Primary outcome
Vitamin B12
Time frame: 1 year
By ELISA Technique, in Pg/ml
Folic Acid
Time frame: 1 year
By ELISA technique, in Pg/ml
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 19330875Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. doi: 10.1002/hep.22759. No abstract available.
- Background: PubMed 12557141Promrat K, McDermott DH, Gonzalez CM, Kleiner DE, Koziol DE, Lessie M, Merrell M, Soza A, Heller T, Ghany M, Park Y, Alter HJ, Hoofnagle JH, Murphy PM, Liang TJ. Associations of chemokine system polymorphisms with clinical outcomes and treatment responses of chronic hepatitis C. Gastroenterology. 2003 Feb;124(2):352-60. doi: 10.1053/gast.2003.50061.
- Background: PubMed 22430955Lam AM, Espiritu C, Bansal S, Micolochick Steuer HM, Niu C, Zennou V, Keilman M, Zhu Y, Lan S, Otto MJ, Furman PA. Genotype and subtype profiling of PSI-7977 as a nucleotide inhibitor of hepatitis C virus. Antimicrob Agents Chemother. 2012 Jun;56(6):3359-68. doi: 10.1128/AAC.00054-12. Epub 2012 Mar 19.
- Background: PubMed 24612116Ampuero J, Romero-Gomez M, Reddy KR. Review article: HCV genotype 3 - the new treatment challenge. Aliment Pharmacol Ther. 2014 Apr;39(7):686-98. doi: 10.1111/apt.12646.
- Background: PubMed 19543577Qamar AA, Grace ND. Abnormal hematological indices in cirrhosis. Can J Gastroenterol. 2009 Jun;23(6):441-5. doi: 10.1155/2009/591317.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhoses and Chronic Hepatitis c, run by Assiut University 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 1 inclusion and 4 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 19 Oct 2020. 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.
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?
Vitamin B12 (time frame: 1 year). 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 NCT03283176, which also lists 5 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 19 Oct 2020.