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| Name | Class |
|---|---|
| Cairo University | OTHER |
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The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients will undergo treatment with different regimens of DAAs.
The study will recruit 150 patients with HCV related HCC All the studied patients underwent or will undergo one of the curative interventions for HCC either hepatic resection or thermal ablation .
after 1 month of achievement of laboratory and radiological response to HCC intervention the patient will be treated with one of the interferon free regimens :
the treatment duration will be justified either 12 or 24 weeks after treatment the patient will continue on regular follow up to detect HCV cure or recurrence , HCC cure or recurrence and long term follow up of natural history
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir +Ribavirin | Experimental | Sofosbuvir 400 mg/day +ribavirin for 24 weeks |
|
| Sofosbuvir+Simeprevir±Ribavirin | Experimental | Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks |
|
| Sofosbuvir+Daclatasvir±Ribavirin | Experimental | Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks |
|
| Sofosbuvir+Ledipasvir±Ribavirin | Experimental | Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir | Drug | Sofosbuvir 400 mg orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment | 12 weeks after the last dose of study drugs |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with virologic failure during treatment or relapse after treatment | from baseline until 12 weeks after the last dose of study drugs | |
| Percentage of Participants who will show any radiological or laboratory changes denoting local or denovo recurrence of HCC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gamal Esmat, MD. | Cairo University | Principal Investigator |
| Aisha El Sharkawy, MD | Cairo University | Study Director |
| Mohamed Hassany, MD | National Hepatology & Tropical Medicine Research Institute (NHTMRI) | Study Director |
| Mai Mehrez, MD. | National Hepatology & Tropical Medicine Research Institute (NHTMRI) | Study Director |
| Amr Maged | National Hepatology & Tropical Medicine Research Institute (NHTMRI) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amr Maged | Cairo | 11441 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29727383 | Derived | Hassany M, Elsharkawy A, Maged A, Mehrez M, Asem N, Gomaa A, Mostafa Z, Abbas B, Soliman M, Esmat G. Hepatitis C virus treatment by direct-acting antivirals in successfully treated hepatocellular carcinoma and possible mutual impact. Eur J Gastroenterol Hepatol. 2018 Aug;30(8):876-881. doi: 10.1097/MEG.0000000000001152. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Informed Consent Form | View IPD |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| D000069616 | Simeprevir |
| C549273 | daclatasvir |
| C586541 | ledipasvir |
| C000595958 | ledipasvir, sofosbuvir drug combination |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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|
| Ribavirin | Drug | Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
|
| Simeprevir | Drug | Simeprevir 150 mg orally once daily |
|
|
| daclatasvir | Drug | Daclatasvir 60 mg orally once daily |
|
|
| Ledipasvir | Drug | Ledipasvir 90 mg orally once daily |
|
|
| Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |