Hepatitis CNCT03247296

Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir

An observational study of Hepatitis C, run by MTI University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hepatitis C
What is being tested?: Sofosbuvir 400 mg, Daclatasvir, Ribavirin
How many people: 200 participants
Where: 1 siteEgypt
Study dates: 28 Feb 2017to 10 Nov 2017
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 75 years
All sexes
Adult, Older adult

Study population: Patients have positive HCV-RNA and taking DAAS to treat it. * Both sexes will be included * Age above 18 to 75 years old * Child Pugh score (A and B) Patients randomly enrolled in the study from the hepatitis clinic in the National Hepatology and Tropical Medicine research Institute

Who may be able to join

Patients have positive HCV-RNA and taking DAAS to treat it.
Both sexes will be included
Age above 18 to 75 years old
Child Pugh score ( A and B )

Who cannot join

Total serum bilirubin<3 mg/dl
Serum albumin > 2.8 g/dl
INR≥ 1.7
Platelet count< 50000/mm3 IF any of the above criteria is not caused by liver disease, the patient can be included in the study.
HCC, except 4 weeks after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI).
Extra- hepatic malignancy.
Pregnancy or inability to use effective contraception.
Inadequately controlled diabetes mellitus (HbA1c>9%).

Trial locations and contacts

1 site in 1 country.

Egypt1 site

National Hepatology and Tropical Medicine Research Institute
Cairo, 11796

Other trials in Egypt

About this study

To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.

Read the detailed description

Methodology:

Design:

Prospective, randomized study used to detect early incidence of HCC in patients taking Sofosbuvir and Daclatasvir to treat HCV.

Patients will be recruited from the National Hepatology and Tropical Medicine Research Institute (NHTMRI)

Duration of study:

24 weeks from starting the DAAs

Methods:

Patients will go through examination and lab. Workup three times in this study:

FIRST time:
Before starting antiviral therapy, all included patients will undergo through physical examination, lab workup including HCV-RNA quantitative, fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, Pregnancy test ( Ladies in child bearing period), AFP as a marker of HCC.
Included patients will also undergo through diagnostic procedures as Abdominal ultrasonography and ECG (men >40, women>50).
Second time:
At the end of antiviral therapy (12 weeks), virological response to therapy will be assessed by quantitative HCV RNA detection, using PCR.
Patients will lab workup including , fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, AFP as a marker of HCC.
The abdominal ultrasonography will be repeated any suspected focal lesion of the liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or the recurrence of HCC.
Third and last time:
At 24 weeks ( Patients will be off treatment for the previous 12 weeks) , virological response to therapy will be assessed by quantitative HCV RNA detection, using PCR.
Patients will lab workup including, fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, AFP as a marker of HCC.
The abdominal ultrasonography will be repeated any suspected focal lesion of the liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or the recurrence of HCC.

Conditions: Hepatitis C
Being tested: Sofosbuvir 400 mg, Daclatasvir, Ribavirin
Keywords: Daclatasvir, HCC, HCV, Sofosbuvir
Medical subject headings: Hepatitis C

What participants receive

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

Sofosbuvir 400 mg, Daclatasvir, RibavirinDrug
No intervention made this is an observational study to monitor the already existing protocols of the facility

Study groups in NCT03247296
Study group	Role	What they receive
Group A		Patients taking Sofosbuvir and Daclatasvir Receives: Drug: Sofosbuvir 400 mg, Daclatasvir, Ribavirin
Group B		Patients taking Sofosbuvir,Daclatasvir, and Ribavirin Receives: Drug: Sofosbuvir 400 mg, Daclatasvir, Ribavirin

What is being measured

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

HCC
occurence of HCC
Measured: 24 weeks

Timeline

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

28 Feb 201710 Nov 2017

First posted11 Aug 2017
Study start28 Feb 2017
Primary completion31 Oct 2017 (estimated)
Study completion10 Nov 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatitis CStudies of the same condition, open and under way.
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: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03247296
Sponsor's protocol ID: 3132010
Status last verified: Aug 2017
First submitted: 9 Aug 2017
Last updated: 11 Aug 2017
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir
ClinicalTrials.gov ID: NCT03247296
Acronym / sponsor ID: 3132010
Conditions: Hepatitis C
Keywords: Daclatasvir, HCC, HCV, Sofosbuvir
Study type: Observational
Recruitment status: Unknown status
Enrolment: 200 participants (actual)
Lead sponsor: MTI UniversityUniversity, hospital or other
Study start: 28 Feb 2017 (actual)
Primary completion: 31 Oct 2017 (estimated)
Study completion: 10 Nov 2017 (estimated)
First posted: 11 Aug 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.

To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.

Detailed description

Methodology:

Design:

Prospective, randomized study used to detect early incidence of HCC in patients taking Sofosbuvir and Daclatasvir to treat HCV.

Patients will be recruited from the National Hepatology and Tropical Medicine Research Institute (NHTMRI)

Duration of study:

24 weeks from starting the DAAs

Methods:

Patients will go through examination and lab. Workup three times in this study:

FIRST time:
Before starting antiviral therapy, all included patients will undergo through physical examination, lab workup including HCV-RNA quantitative, fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, Pregnancy test ( Ladies in child bearing period), AFP as a marker of HCC.
Included patients will also undergo through diagnostic procedures as Abdominal ultrasonography and ECG (men >40, women>50).
Second time:
At the end of antiviral therapy (12 weeks), virological response to therapy will be assessed by quantitative HCV RNA detection, using PCR.
Patients will lab workup including , fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, AFP as a marker of HCC.
The abdominal ultrasonography will be repeated any suspected focal lesion of the liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or the recurrence of HCC.
Third and last time:
At 24 weeks ( Patients will be off treatment for the previous 12 weeks) , virological response to therapy will be assessed by quantitative HCV RNA detection, using PCR.
Patients will lab workup including, fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, AFP as a marker of HCC.
The abdominal ultrasonography will be repeated any suspected focal lesion of the liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or the recurrence of HCC.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Group A	–	Drug: Sofosbuvir 400 mg, Daclatasvir, RibavirinPatients taking Sofosbuvir and Daclatasvir
Group B	–	Drug: Sofosbuvir 400 mg, Daclatasvir, RibavirinPatients taking Sofosbuvir,Daclatasvir, and Ribavirin

Who may qualify

Ages: 18 to 75 years
Sex: All
Age groups: Adult, Older adult
Study population: Patients have positive HCV-RNA and taking DAAS to treat it. * Both sexes will be included * Age above 18 to 75 years old * Child Pugh score (A and B) Patients randomly enrolled in the study from the hepatitis clinic in the National Hepatology and Tropical Medicine research Institute

Key inclusion criteria (4 listed)

Patients have positive HCV-RNA and taking DAAS to treat it.
Both sexes will be included
Age above 18 to 75 years old
Child Pugh score ( A and B )

Key exclusion criteria (8 listed)

Total serum bilirubin<3 mg/dl
Serum albumin > 2.8 g/dl
INR≥ 1.7
Platelet count< 50000/mm3 IF any of the above criteria is not caused by liver disease, the patient can be included in the study.
HCC, except 4 weeks after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI).

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
Sofosbuvir 400 mg, Daclatasvir, RibavirinNo intervention made this is an observational study to monitor the already existing protocols of the facility	Drug	Group A, Group B

Primary outcome

HCC
Time frame: 24 weeks
occurence of HCC

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

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.

Nagwa A Sabri, Professor study chair

Professor and Head of Clinical Pharmacy Department Faculty of Pharmacy Ain Shams University

Abd El Rahman El Naggar, Professor study director

Professor of clinicalpharmacology and Toxicology and Head of clinical pharmacy Department MTI University

Hasan A El Garem, Professor study director

Prof. Dr. of Endemic Medicine, hepatology, and gastroenterology Faculty of Medicine Cairo University

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 Hepatitis C, run by MTI 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 4 inclusion and 8 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 Aug 2017. 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?

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?

HCC (time frame: 24 weeks). 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 NCT03247296.

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 Aug 2017.