- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01821963
Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)
Telaprevir in Combination With Standard of Care in Hepatitis C Genotype 1 Infection in Patients With Hepatocellular Carcinoma Awaiting Liver Transplantation
The goal of this clinical research study is to learn if the antiviral combination of telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the virus from coming back after the liver transplant.
Telaprevir, PegIFN alfa-2a, and RBV are different antiviral drugs that work in combination at different stages of the HCV infection to stop the virus.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take telaprevir 3 times a day. You will take RVB by mouth 2 times a day. You will receive PEGIFN alfa-2a by an injection under the skin 1 time a week.
Study Visits:
On the first day you take the study drug:
- You will have an eye exam performed by the study doctor.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis virus.
- You will be asked about any drugs you are taking or side effects you may be having.
Every Week while you are on study:
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis C virus. If part of the blood sample is left over after the Hepatitis C testing, it will be stored in the laboratory as a back-up sample, in case the original samples get lost. This sample may also be used to check if the Hepatitis C virus has become resistant to the study drug. No extra blood will be drawn for this storage.
- You will be asked about any drugs you are taking or side effects you may be having.
- At Weeks 12, 24, 36, and 42, urine will be collected to check for infection and any other side effects to the drugs.
If you can become pregnant, you will have a urine pregnancy test every 4 weeks
Length of Treatment:
You may continue receiving the antiviral therapy for up to 48 weeks, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits.
Follow-Up Visits:
Beginning the day after you stop taking antiviral therapy (or the day of transplantation, whichever comes first), you will have up to 24 weeks of follow-up testing performed. About 4 and 20 weeks after your last dose:
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis C virus.
- You will be asked about any side effects you may be having.
- At week 4 only, urine will be collected to check for infection and any other side effects to the drugs.
This is an investigational study. Telaprevir, PegIFN alfa-2a, and RBV are all FDA approved and commercially available for the treatment of HCV infection. The use of these drugs in preventing the HCV infection is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- University of Texas MD Anderson Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Males or females aged ≥ 18 and ≤ 70 years
- Detectable Hepatitis C Virus ribonucleic acid (HCV-RNA) in serum
- HCV genotype 1 infection
- Child-Pugh-Turcotte (CPT) score < 7 and Model for End-Stage Liver Disease (MELD) score < 18
- PegIFN alfa-2a/RBV-naïve or previously treated patients (partial responders, null responders and relapsers)
Hepatocellular carcinoma within transplant criteria in the United Network for Organ Sharing (UNOS) Region IV:
- Single lesion up to 6 cm, or
- Two or three lesions with largest no greater than 5 cm and the total tumor diameter no greater than 9 cm
- Listed for liver transplantation
- Willingness to give written consent and agree to double contraception
Exclusion Criteria:
- Decompensated cirrhosis
- Baseline platelet count less than 35,000/µL
- Baseline hemoglobin level less than 10 g/dL
- Baseline absolute neutrophil count less than 750/mm3
- Baseline creatinine clearance < 50 mL per min.
- Women with a positive pregnancy test at baseline or men whose female partners are pregnant or are contemplating pregnancy
- Intolerance or contraindications to PegIFN alfa-2a/RBV use per standard treatment guidelines
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir
Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin.
Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first.
Starting doses for standard of care pegylated interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for telaprevir 750 mg taken orally 3 times a day.
|
Starting dose: 180 mcg subcutaneously once weekly.
Andre navn:
Starting dose: 1,000 mg by mouth daily.
Starting dose: 750 mg by mouth 3 times a day.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant
Tidsramme: 12 weeks post-transplant, up to 48 weeks for overall monitoring
|
The primary endpoint is number of participants with undetectable viral load at 12 weeks post-transplant (Post-transplant virological response, (PTVR)) which is defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) 12 weeks after liver transplantation). In order to have undetectable HCV RNA viral load after transplant, participants need to have undetectable viral load before the liver transplant. Response rate based on the modified intent-to-treat (ITT) population where ITT population is defined as those patients who have achieved an undetectable HCV-RNA level before the transplant. If patients drop out the study early due to severe toxicity or treatment failure including treatment-related death, they will be counted as non-responders when evaluating the response rate. |
12 weeks post-transplant, up to 48 weeks for overall monitoring
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Sustained Virological Response (SVR)
Tidsramme: 60 weeks
|
Sustained virological response (SVR) defined as a single undetectable HCV-RNA measurement 12 weeks after the 48-week treatment period for those still waiting for transplantation.
The treatment duration will be summarized with descriptive statistics.
Additional analyses based on evaluable patients also conducted regarding the PTVR response rate.
The evaluable patients are defined as those patients who complete at least 16 weeks of treatment and have the 12 weeks post-transplant response measurement.
The rate will also be computed stratified by the HCV treatment time (i.e., the 48-week HCV treatment versus less than 48 week HCV treatment) considering the different times under HCV.
The SVR rate will be estimated, along with the exact 95% confident interval.
|
60 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Patologiske prosesser
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Adenokarsinom
- Neoplasmer, kjertel og epitel
- Sykdomsattributter
- Neoplasmer i fordøyelsessystemet
- Leversykdommer
- Neoplasmer i leveren
- Karsinom
- Infeksjoner
- Smittsomme sykdommer
- Karsinom, hepatocellulært
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Antimetabolitter
- Antineoplastiske midler
- Immunologiske faktorer
- Interferoner
- Interferon-alfa
- Ribavirin
- Peginterferon alfa-2a
- Interferon alfa-2
Andre studie-ID-numre
- 2012-0977
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Infeksjon
-
Universidad del DesarrolloFullførtHealthcare Associated InfectionChile
-
Imelda Hospital, BonheidenFullførtHealthcare Associated InfectionBelgia
-
Centre Hospitalier Universitaire de NīmesRekrutteringEldre | Healthcare Associated InfectionFrankrike
-
Centre Hospitalier Universitaire, AmiensFullførtHealthcare Associated Infection | IglerFrankrike
-
Johns Hopkins UniversityFullførtHealthcare Associated Infection | Multiresistente organismer
-
University of PennsylvaniaFullførtAntimikrobiell resistensForente stater, Botswana
-
University of Maryland, BaltimoreVA Office of Research and DevelopmentFullførtMenneskelig mikrobiomForente stater
-
Universidad Autonoma de Nuevo LeonUkjentHelsetilknyttede infeksjoner
-
Children's Hospital Medical Center, CincinnatiAvsluttetAllogen hematopoetisk celletransplantasjonForente stater
-
Central Hospital, Nancy, FranceHar ikke rekruttert ennåHealthcare Associated Infection | Antibiotika
Kliniske studier på Pegylated Interferon Alfa 2a
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AvsluttetBrystkreft | Metastatisk kreftForente stater
-
Kaohsiung Medical University Chung-Ho Memorial...Fullført
-
University Hospital TuebingenDermatologic Cooperative Oncology GroupFullført
-
Huashan HospitalUkjent
-
Pusan National University HospitalUkjentKronisk hepatitt BKorea, Republikken
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)FullførtSvulster i hjernen og sentralnervesystemetForente stater
-
BioGeneric PharmaXiamen Amoytop Biotech Co., Ltd.UkjentHepatitt C | Følelse av mestringsevneEgypt
-
Hoffmann-La RocheFullførtNyrecellekarsinom | Kronisk myelogen leukemi | Ondartet melanomCanada, India, Bulgaria, Den russiske føderasjonen, Spania, Sør-Afrika, Slovakia
-
Vir Biotechnology, Inc.Alnylam PharmaceuticalsAktiv, ikke rekrutterendeKronisk hepatitt BAustralia, Hong Kong, Korea, Republikken, Malaysia, New Zealand, Thailand
-
Kaohsiung Medical University Chung-Ho Memorial...Fullført