Hepatitis CNCT03241823
Assessment of Patients With Hepatitis C Virus Related Liver Cirrhosis After Sustained Response to Direct Acting Anti Viral Drugs.
An observational study of Hepatitis C and Liver Cirrhosis, run by Assiut University at 1 site in Egypt.
Trial summary
Hepatitis C Virus (HCV) infection is a major global health challenge; it is estimated that more than 80 million people are chronically infected worldwide, with 3-4 million new infections and 350,000 deaths occurring each year because of HCV-related complications . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Liver Cirrhosis
- What is being tested?
- Abdominal ultrasound ., Model for End-Stage Liver Disease and Fibro Scan.
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients with chronic hepatitis C virus related liver cirrhosis who achieved Sustained virological response after direct acting antiviral drugs (Sofosbuvir, Daclatasvir ± Ribavirin) and other available suitable regimens for 12 or 24 weeks will be selected from Assuit unit of treatment of viral hepatitis.
Who may be able to join
- Age: ≥ 18 years.
- Disease status: patients with hepatitis C Virus related liver cirrhosis child A\& B (scores 5-9).
- Previous treatment: treatment naïve and treatment experienced.
- HCV RNA: Negative at any point between 12-24 weeks post treatment to confirm successful eradication of the virus.
- Negative HBsAg and HIV antibody.
- Normal kidney function test
Who cannot join
- Child C liver cirrhosis (Child score ≥ 10).
- HCV coinfection with HBV or HIV.
- Patients with high risk of infection (I.V drug users, patients with blood disease requiring blood transfusion).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assuit Unit of Treatment of Viral Hepatitis.
Asyut, 71111
Waleed Hassan, MD, 00201020066191, wallo403a@yahoo.com
About this study
Official title: Assessment of Hepatic Fibrosis, Hemodynamics, and Disease Severity of Patients With Hepatitis C Virus Related Liver Cirrhosis After Sustained Response to Direct Acting Anti Viral Drugs.
Hepatitis C Virus (HCV) infection is a major global health challenge; it is estimated that more than 80 million people are chronically infected worldwide, with 3-4 million new infections and 350,000 deaths occurring each year because of HCV-related complications .
Read the detailed description
In 2015, a national Egyptian health issue survey was conducted to describe the prevalence of hepatitis C virus infection. The prevalence of hepatitis C virus antibody was found to be 10.0% and that of Hepatitis C virus Ribonucleic acid (HCV RNA ) to be 7.0% in the age group between 15-59 years. While In children, 1-14 years old, the prevalence of Hepatitis C virus (HCV) antibody and Hepatitis C virus Ribonucleic acid (HCV RNA) were 0.4% and 0.2% respectively.
The primary goal of HCV therapy is to cure the infection, i.e. to achieve a sustained virological response (SVR) defined as undetectable Hepatitis C virus Ribonucleic acid (HCV RNA )12 weeks or 24 weeks after treatment completion. The infection is cured in more than 99% of patients who achieve asustained virological response (SVR). Asustained virological response (SVR) is generally associated with normalization of liver enzymes and improvement or disappearance of liver necroinflammation and fibrosis in patients without cirrhosis. Patients with severe liver disease remain at risk of life-threatening complications; however hepatic fibrosis may regress and the risk of complications such as hepatic failure and portal hypertension is reduced .
Previous data suggest that the risk of Hepatocellular carcinoma and all-cause mortality is significantly reduced, but not eliminated, in cirrhotic patients who clear Hepatitis C Virus compared to untreated patients and non-sustained virological responders . Hepatitis C Virus is also associated with a number of extrahepatic manifestations and effective viral suppression induces reversal of most of them .
Studies in those with hepatitis C-related decompensated cirrhosis have demonstrated that sustained virological response can indeed be achieved in the majority of these individuals, and short-term follow-up from these studies has shown that Sustained virological response is often accompanied by improvement in measures of decompensation including Model for End-Stage Liver Disease (MELD) score and Child-Turcotte-Pugh (CPT) score. Moreover, because hepatitis C recurrence after Orthotopic liver transplantation is associated with worse outcomes, achieving Sustained virological response before transplant in a decompensated population with chronic hepatitis C will likely allow these patients to achieve long-term outcomes not different from non-Hepatitis C virus-infected populations .
In the SOLAR-1 and SOLAR-2 studies, those with decompensated cirrhosis with genotypes 1 and 4 were randomized to receive sofosbuvir/ledipasvir with low-dose ribavirin for 12 or 24 weeks . No difference was seen in Sustained virological response in the 12- or 24-week arms, and the therapy was well tolerated. Moreover, these studies both reported improvement in Model for End-Stage Liver Disease (MELD) score and Child-Turcotte-Pugh (CPT) scores 4 weeks after therapy had been stopped with longer-term follow-up results expected.
Liver stiffness measurement by transient elastography is a noninvasive, painless, rapid, and objective method for the evaluation of fibrosis or cirrhosis . Systemic reviews and meta-analyses have demonstrated the high sensitivity and specificity of Liver stiffness measurement in the diagnosis of hepatic cirrhosis.
In a systematic review conducted at 2007, repoted that at a threshold of approximately 0.60, the sensitivity and specificity of the FibroTest were 47% (35-59%) and 90% (87-92%). For FibroScan (threshold approximately 8 kPa), corresponding values were 64% (50-76%) and 87% (80-91%), respectively.
In another systematic review conducted at 2010, reported that the pooled estimates for sensitivity of fibroscan were 87% (84%-90%), specificity 91% (89%-92%) in stage IV fibrosis (cirrhosis). While in patients with stages II-IV fibrosis, they reported that the pooled estimates for sensitivity were 70% (67%-73%), specificity 84% (80%-88%).
Multicenter observational, cohort, prospective study included 90 patients with hepatitis C genotype 1 treated with telaprevir or boceprevir who had advanced fibrosis evidenced by liver stiffness and achieved Sustained virological response reported that liver stiffness was significantly reduced 2 weeks after treatment. This suggested the possibility of liver cirrhosis regression evidenced by liver stiffness after sustained virological response in a significant proportion of patients .
In a study included 182 Egyptian patients with HCV infection to validate and compare the diagnostic performance of Fibroscan , APRI Score , FIB4 for the prediction of hepatic fibrosis and treatment outcome in HCV infected patients receiving pegylated interferon and ribavirin, the authors reported that Fibroscan and noninvasive scores as APRI , FIB4 can be used as good predictors of liver fibrosis in chronic hepatitis C. However, they are not good predictors of response to pegylated interferon and ribavirin .
In a study 2010, they concluded that liver stiffness measurement can be useful for monitoring regression of liver fibrosis during entecavir treatment in patients with chronic hepatitis B virus infection.
A few studies showed a consistent relationship between Doppler Ultrasonography findings and liver histology. showed that Doppler Ultrasound findings are sensitive to haemo dynamic changes in liver fibrosis. Doppler Ultrasonography scoring was significantly related to liver fibrosis staging.
The Doppler Ultrasound signs for portal hypertension are: (1) reduced portal vein blood flow velocity (time-averaged mean vel. < 14-16 cm/s2), with sensitivity and specificity between 80-88% and 80-96%, respectively; (2) portal vein congestion index > 0.08. This parameter, however, is not used routinely, probably due to its being difficult to measure and its lower reproducibility; and (3) measurements of the hepatic arterial Resistive Index are less useful. In the course of Liver cirrhosis, the appearance of clinically significant portal hypertension worsens prognosis and Doppler ultrasound is very useful in evaluating portal hypertension. . astudy showed a significant reverse correlation between the velocities of the main portal vein and fibrous staging of the liver.
- Conditions
- Hepatitis C, Liver Cirrhosis
- Being tested
- Abdominal ultrasound ., Model for End-Stage Liver Disease, Fibro Scan., Child-Turcotte-Pugh score.
- Medical subject headings
- Hepatitis C, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasound .Diagnostic test
Abdominal ultrasound for each patient before and after treatment.
Model for End-Stage Liver DiseaseDiagnostic test
Model for End-Stage Liver Disease before and after treatment.
Fibro Scan.Diagnostic test
Liver stiffness by Fibro scan before and after treatment.
Child-Turcotte-Pugh score.Diagnostic test
Child-Turcotte-Pugh score before and after treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients with hepatitis c virus related liver cirrhosis | Patients with chronic hepatitis C virus whose ultrasound shows liver cirrhosis, fibroscan "F3 and F4, Child score "A and B", of any MELD score, who achieved Sustained Virological Response after direct acting antiviral drugs (Sofosbuvir, Daclatasvir ± Ribavirin). Receives: Diagnostic Test: Abdominal ultrasound .; Diagnostic Test: Model for End-Stage Liver Disease; Diagnostic Test: Fibro Scan.; Diagnostic Test: Child-Turcotte-Pugh score. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in liver fibrosis
Using non-invasive measures "Fibroscan"
Measured: 1 year.
Secondary outcomes (2)
Changes occurring in liver haemodynamics
Using Doppler ultrasound.
Measured: 1 year.
Changes in severity of liver disease
Using Child-Pugh score.
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 posted8 Aug 2017
- Study start1 Dec 2017 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
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 Hepatitis CStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Taha, Assiut University
- Investigators
- Ibrahim Taha, MSc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241823
- Sponsor's protocol ID
- AOHF
- Status last verified
- Aug 2017
- First submitted
- 3 Aug 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arase Y, Kobayashi M, Suzuki F, Suzuki Y, Kawamura Y, Akuta N, Kobayashi M, Sezaki H, Saito S, Hosaka T, Ikeda K, Kumada H, Kobayashi T. Effect of type 2 diabetes on risk for malignancies includes hepatocellular carcinoma in chronic hepatitis C. Hepatology. 2013 Mar;57(3):964-73. doi: 10.1002/hep.26087. Epub 2013 Feb 7.
PubMed 22991257Bruno S, Di Marco V, Iavarone M, Roffi L, Crosignani A, Calvaruso V, Aghemo A, Cabibbo G, Vigano M, Boccaccio V, Craxi A, Colombo M, Maisonneuve P. Survival of patients with HCV cirrhosis and sustained virologic response is similar to the general population. J Hepatol. 2016 Jun;64(6):1217-23. doi: 10.1016/j.jhep.2016.01.034. Epub 2016 Apr 5.
PubMed 27059129Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS Jr, Fried MW, Terrault NA, O'Leary JG, Vargas HE, Kuo A, Schiff E, Sulkowski MS, Gilroy R, Watt KD, Brown K, Kwo P, Pungpapong S, Korenblat KM, Muir AJ, Teperman L, Fontana RJ, Denning J, Arterburn S, Dvory-Sobol H, Brandt-Sarif T, Pang PS, McHutchison JG, Reddy KR, Afdhal N; SOLAR-1 Investigators. Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. Gastroenterology. 2015 Sep;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. Epub 2015 May 15.
PubMed 25985734Claudon M, Dietrich CF, Choi BI, Cosgrove DO, Kudo M, Nolsoe CP, Piscaglia F, Wilson SR, Barr RG, Chammas MC, Chaubal NG, Chen MH, Clevert DA, Correas JM, Ding H, Forsberg F, Fowlkes JB, Gibson RN, Goldberg BB, Lassau N, Leen EL, Mattrey RF, Moriyasu F, Solbiati L, Weskott HP, Xu HX; World Federation for Ultrasound in Medicine; European Federation of Societies for Ultrasound. Guidelines and good clinical practice recommendations for Contrast Enhanced Ultrasound (CEUS) in the liver - update 2012: A WFUMB-EFSUMB initiative in cooperation with representatives of AFSUMB, AIUM, ASUM, FLAUS and ICUS. Ultrasound Med Biol. 2013 Feb;39(2):187-210. doi: 10.1016/j.ultrasmedbio.2012.09.002. Epub 2012 Nov 5.
PubMed 23137926Enomoto M, Mori M, Ogawa T, Fujii H, Kobayashi S, Iwai S, Morikawa H, Tamori A, Sakaguchi H, Sawada A, Takeda S, Habu D, Shiomi S, Kawada N. Usefulness of transient elastography for assessment of liver fibrosis in chronic hepatitis B: Regression of liver stiffness during entecavir therapy. Hepatol Res. 2010 Sep;40(9):853-61. doi: 10.1111/j.1872-034X.2010.00687.x.
PubMed 20887589
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hepatic Fibrosis, Hemodynamics, and Disease Severity of Patients With Hepatitis C Virus Related Liver Cirrhosis After Sustained Response to Direct Acting Anti Viral Drugs.
- ClinicalTrials.gov ID
- NCT03241823
- Acronym / sponsor ID
- AOHF
- Conditions
- Hepatitis C, Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 8 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.
Hepatitis C Virus (HCV) infection is a major global health challenge; it is estimated that more than 80 million people are chronically infected worldwide, with 3-4 million new infections and 350,000 deaths occurring each year because of HCV-related complications .
Detailed description
In 2015, a national Egyptian health issue survey was conducted to describe the prevalence of hepatitis C virus infection. The prevalence of hepatitis C virus antibody was found to be 10.0% and that of Hepatitis C virus Ribonucleic acid (HCV RNA ) to be 7.0% in the age group between 15-59 years. While In children, 1-14 years old, the prevalence of Hepatitis C virus (HCV) antibody and Hepatitis C virus Ribonucleic acid (HCV RNA) were 0.4% and 0.2% respectively.
The primary goal of HCV therapy is to cure the infection, i.e. to achieve a sustained virological response (SVR) defined as undetectable Hepatitis C virus Ribonucleic acid (HCV RNA )12 weeks or 24 weeks after treatment completion. The infection is cured in more than 99% of patients who achieve asustained virological response (SVR). Asustained virological response (SVR) is generally associated with normalization of liver enzymes and improvement or disappearance of liver necroinflammation and fibrosis in patients without cirrhosis. Patients with severe liver disease remain at risk of life-threatening complications; however hepatic fibrosis may regress and the risk of complications such as hepatic failure and portal hypertension is reduced .
Previous data suggest that the risk of Hepatocellular carcinoma and all-cause mortality is significantly reduced, but not eliminated, in cirrhotic patients who clear Hepatitis C Virus compared to untreated patients and non-sustained virological responders . Hepatitis C Virus is also associated with a number of extrahepatic manifestations and effective viral suppression induces reversal of most of them .
Studies in those with hepatitis C-related decompensated cirrhosis have demonstrated that sustained virological response can indeed be achieved in the majority of these individuals, and short-term follow-up from these studies has shown that Sustained virological response is often accompanied by improvement in measures of decompensation including Model for End-Stage Liver Disease (MELD) score and Child-Turcotte-Pugh (CPT) score. Moreover, because hepatitis C recurrence after Orthotopic liver transplantation is associated with worse outcomes, achieving Sustained virological response before transplant in a decompensated population with chronic hepatitis C will likely allow these patients to achieve long-term outcomes not different from non-Hepatitis C virus-infected populations .
In the SOLAR-1 and SOLAR-2 studies, those with decompensated cirrhosis with genotypes 1 and 4 were randomized to receive sofosbuvir/ledipasvir with low-dose ribavirin for 12 or 24 weeks . No difference was seen in Sustained virological response in the 12- or 24-week arms, and the therapy was well tolerated. Moreover, these studies both reported improvement in Model for End-Stage Liver Disease (MELD) score and Child-Turcotte-Pugh (CPT) scores 4 weeks after therapy had been stopped with longer-term follow-up results expected.
Liver stiffness measurement by transient elastography is a noninvasive, painless, rapid, and objective method for the evaluation of fibrosis or cirrhosis . Systemic reviews and meta-analyses have demonstrated the high sensitivity and specificity of Liver stiffness measurement in the diagnosis of hepatic cirrhosis.
In a systematic review conducted at 2007, repoted that at a threshold of approximately 0.60, the sensitivity and specificity of the FibroTest were 47% (35-59%) and 90% (87-92%). For FibroScan (threshold approximately 8 kPa), corresponding values were 64% (50-76%) and 87% (80-91%), respectively.
In another systematic review conducted at 2010, reported that the pooled estimates for sensitivity of fibroscan were 87% (84%-90%), specificity 91% (89%-92%) in stage IV fibrosis (cirrhosis). While in patients with stages II-IV fibrosis, they reported that the pooled estimates for sensitivity were 70% (67%-73%), specificity 84% (80%-88%).
Multicenter observational, cohort, prospective study included 90 patients with hepatitis C genotype 1 treated with telaprevir or boceprevir who had advanced fibrosis evidenced by liver stiffness and achieved Sustained virological response reported that liver stiffness was significantly reduced 2 weeks after treatment. This suggested the possibility of liver cirrhosis regression evidenced by liver stiffness after sustained virological response in a significant proportion of patients .
In a study included 182 Egyptian patients with HCV infection to validate and compare the diagnostic performance of Fibroscan , APRI Score , FIB4 for the prediction of hepatic fibrosis and treatment outcome in HCV infected patients receiving pegylated interferon and ribavirin, the authors reported that Fibroscan and noninvasive scores as APRI , FIB4 can be used as good predictors of liver fibrosis in chronic hepatitis C. However, they are not good predictors of response to pegylated interferon and ribavirin .
In a study 2010, they concluded that liver stiffness measurement can be useful for monitoring regression of liver fibrosis during entecavir treatment in patients with chronic hepatitis B virus infection.
A few studies showed a consistent relationship between Doppler Ultrasonography findings and liver histology. showed that Doppler Ultrasound findings are sensitive to haemo dynamic changes in liver fibrosis. Doppler Ultrasonography scoring was significantly related to liver fibrosis staging.
The Doppler Ultrasound signs for portal hypertension are: (1) reduced portal vein blood flow velocity (time-averaged mean vel. < 14-16 cm/s2), with sensitivity and specificity between 80-88% and 80-96%, respectively; (2) portal vein congestion index > 0.08. This parameter, however, is not used routinely, probably due to its being difficult to measure and its lower reproducibility; and (3) measurements of the hepatic arterial Resistive Index are less useful. In the course of Liver cirrhosis, the appearance of clinically significant portal hypertension worsens prognosis and Doppler ultrasound is very useful in evaluating portal hypertension. . astudy showed a significant reverse correlation between the velocities of the main portal vein and fibrous staging of the liver.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hepatitis c virus related liver cirrhosis | – | Diagnostic Test: Abdominal ultrasound ., Diagnostic Test: Model for End-Stage Liver Disease, Diagnostic Test: Fibro Scan., Diagnostic Test: Child-Turcotte-Pugh score.Patients with chronic hepatitis C virus whose ultrasound shows liver cirrhosis, fibroscan "F3 and F4, Child score "A and B", of any MELD score, who achieved Sustained Virological Response after direct acting antiviral drugs (Sofosbuvir, Daclatasvir ± Ribavirin). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients with chronic hepatitis C virus related liver cirrhosis who achieved Sustained virological response after direct acting antiviral drugs (Sofosbuvir, Daclatasvir ± Ribavirin) and other available suitable regimens for 12 or 24 weeks will be selected from Assuit unit of treatment of viral hepatitis.
Key inclusion criteria (6 listed)
- Age: ≥ 18 years.
- Disease status: patients with hepatitis C Virus related liver cirrhosis child A\& B (scores 5-9).
- Previous treatment: treatment naïve and treatment experienced.
- HCV RNA: Negative at any point between 12-24 weeks post treatment to confirm successful eradication of the virus.
- Negative HBsAg and HIV antibody.
Key exclusion criteria (3 listed)
- Child C liver cirrhosis (Child score ≥ 10).
- HCV coinfection with HBV or HIV.
- Patients with high risk of infection (I.V drug users, patients with blood disease requiring blood transfusion).
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 |
|---|---|---|
| Abdominal ultrasound .Abdominal ultrasound for each patient before and after treatment. | Diagnostic test | Patients with hepatitis c virus related liver cirrhosis |
| Model for End-Stage Liver DiseaseModel for End-Stage Liver Disease before and after treatment. | Diagnostic test | Patients with hepatitis c virus related liver cirrhosis |
| Fibro Scan.Liver stiffness by Fibro scan before and after treatment. | Diagnostic test | Patients with hepatitis c virus related liver cirrhosis |
| Child-Turcotte-Pugh score.Child-Turcotte-Pugh score before and after treatment | Diagnostic test | Patients with hepatitis c virus related liver cirrhosis |
Primary outcome
Changes in liver fibrosis
Time frame: 1 year.
Using non-invasive measures "Fibroscan"
2 secondary outcomes
Changes occurring in liver haemodynamics
Time frame: 1 year.
Changes in severity of liver disease
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Background: PubMed 22991257Arase Y, Kobayashi M, Suzuki F, Suzuki Y, Kawamura Y, Akuta N, Kobayashi M, Sezaki H, Saito S, Hosaka T, Ikeda K, Kumada H, Kobayashi T. Effect of type 2 diabetes on risk for malignancies includes hepatocellular carcinoma in chronic hepatitis C. Hepatology. 2013 Mar;57(3):964-73. doi: 10.1002/hep.26087. Epub 2013 Feb 7.
- Background: PubMed 27059129Bruno S, Di Marco V, Iavarone M, Roffi L, Crosignani A, Calvaruso V, Aghemo A, Cabibbo G, Vigano M, Boccaccio V, Craxi A, Colombo M, Maisonneuve P. Survival of patients with HCV cirrhosis and sustained virologic response is similar to the general population. J Hepatol. 2016 Jun;64(6):1217-23. doi: 10.1016/j.jhep.2016.01.034. Epub 2016 Apr 5.
- Background: PubMed 25985734Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS Jr, Fried MW, Terrault NA, O'Leary JG, Vargas HE, Kuo A, Schiff E, Sulkowski MS, Gilroy R, Watt KD, Brown K, Kwo P, Pungpapong S, Korenblat KM, Muir AJ, Teperman L, Fontana RJ, Denning J, Arterburn S, Dvory-Sobol H, Brandt-Sarif T, Pang PS, McHutchison JG, Reddy KR, Afdhal N; SOLAR-1 Investigators. Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. Gastroenterology. 2015 Sep;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. Epub 2015 May 15.
- Background: PubMed 23137926Claudon M, Dietrich CF, Choi BI, Cosgrove DO, Kudo M, Nolsoe CP, Piscaglia F, Wilson SR, Barr RG, Chammas MC, Chaubal NG, Chen MH, Clevert DA, Correas JM, Ding H, Forsberg F, Fowlkes JB, Gibson RN, Goldberg BB, Lassau N, Leen EL, Mattrey RF, Moriyasu F, Solbiati L, Weskott HP, Xu HX; World Federation for Ultrasound in Medicine; European Federation of Societies for Ultrasound. Guidelines and good clinical practice recommendations for Contrast Enhanced Ultrasound (CEUS) in the liver - update 2012: A WFUMB-EFSUMB initiative in cooperation with representatives of AFSUMB, AIUM, ASUM, FLAUS and ICUS. Ultrasound Med Biol. 2013 Feb;39(2):187-210. doi: 10.1016/j.ultrasmedbio.2012.09.002. Epub 2012 Nov 5.
- Background: PubMed 20887589Enomoto M, Mori M, Ogawa T, Fujii H, Kobayashi S, Iwai S, Morikawa H, Tamori A, Sakaguchi H, Sawada A, Takeda S, Habu D, Shiomi S, Kawada N. Usefulness of transient elastography for assessment of liver fibrosis in chronic hepatitis B: Regression of liver stiffness during entecavir therapy. Hepatol Res. 2010 Sep;40(9):853-61. doi: 10.1111/j.1872-034X.2010.00687.x.
- Individual participant dataSharing planned: Undecided
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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.
Ibrahim Taha, MSc principal investigator
Assiut 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 and Liver Cirrhosis, 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 6 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 8 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?
Contact Sherif Kamel, MD (00201222303690, shereef_kamel@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in liver fibrosis (time frame: 1 year.). 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 NCT03241823, 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 8 Aug 2017.