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NCT03520660Fut, nem toboroz4. fázis

People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents

Long-Term Follow-Up Of Subjects With CHC Who Achieved A Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 22.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

Background: Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people. But some keep getting complications even after it is cured. Researchers want to study why. Objective: To study the course and complications of liver disease after cure of hepatitis C infection. Eligibility: Adults 18 years and older infected with chronic hepatitis C virus who were never treated or were treated and not cured and those who were cured Design: Participants will be screened with: Blood and urine tests Questionnaires Liver ultrasound Fibroscan. A probe vibrates the liver, testing stiffness. In Phase 1, people with chronic hepatitis C will: Have a 3-day hospital admission to repeat some screening tests and have a liver biopsy. A small piece of liver is removed by needle passed through the skin. Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks. Repeat some blood tests at 3 visits in those 12 weeks while on treatment, then 4 additional visits in the next 24 weeks with more blood work collected. Phase 1 participants who test negative for hepatitis C and all other eligible participants will enter Phase 2. Phase 2 participants will have a visit every 24 weeks for 10 years. These may include: Repeats of screening tests Questionnaires Scans Stool tests Chest x-ray Heart function test Endoscopy. A tube guides a camera into the upper digestive system. At about 5 years, participants will have another liver biopsy. Some participants will give separate consent for genetic testing and a special blood procedure.

Állapot (regiszter)
Fut, nem toboroz
Fázis (regiszter)
4. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
121 (tényleges)
Első benyújtás
2018. máj. 9.
Kezdés
2018. okt. 19.
Elsődleges befejezés
2032. dec. 31.
Fő szponzor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT-szám
NCT03520660

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 4. fázis
  • Bevont résztvevők: 121
  • 2018. okt. 19. és az elsődleges befejezés (2032. dec. 31.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Prior treatment with a NS5a agent
  • Clinically relevant drug abuse based on patient history within 12 months of screening.
  • Use of medications contraindicated with use of sofosbuvir/velpatasvir within 21 days of the Baseline/Day 1 visit; this washout period does not apply to proton pump inhibitors, which can be taken up to 7 days before baseline Day 1 for the following:
    • Acid reducing Agents
    • Antiarrhythmics
    • Anticancer
    • Antimycobacterial
    • HIV antivirals
    • Herbal supplements
    • HMG-CoA Reductase Inhibitors
  • Use of antiviral medications within the last 30 days.
  • Solid organ transplantation

Más betegség

  • Chronic liver disease of a non-HCV etiology with the exception of steatosis (e.g., chronic hepatitis B, hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis).
  • Known hypersensitivity to sofosbuvir and velpatasvir, or formulation excipients.
  • Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study.
  • Presence of conditions that, in the opinion of the investigators, would not allow the subject to n the current study for at least 1 year.
    • Phase II Follow-up

Laborértékek

  • Current or prior history of any of the following:
    • Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded
    • Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
    • Decompensated liver disease as defined by serum bilirubin >= 2.5 mg/dL (with direct bilirubin >= 1.5 mg/dL), INR >1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding, or hepatic encephalopathy
    • Solid organ transplantation
    • Significant pulmonary disease, significant cardiac disease
  • Co-infection with HIV defined as the presence of anti-HIV in serum.
  • Current or prior history of any of the following:
    • Clinically significant illness (other than resolved HCV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness
    • (other than HCV) are also excluded
    • --Decompensated liver disease as defined by serum bilirubin >= 2.5 mg/dL (with direct
    • bilirubin >= 1.5 mg/dL), INR >1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding, or hepatic encephalopathy.
  • Significant pulmonary disease, significant cardiac disease
    • History of malignancy or treatment for a malignancy within the past 3 years that is associated with a life expectancy <5 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin)
    • Chronic liver disease with the exception of steatosis (e.g., chronic hepatitis B, hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis)
    • Evidence of harmful or hazardous drinking as defined as a score >= 8 on the AUDIT questionnaire
    • Co-infection with HIV defined as the presence of anti-HIV in serum
    • Clinically relevant drug abuse based on patient history within 12 months of screening
    • Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent >= 10 mg/day)
    • Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alpha-fetoprotein level of greater than 500 mg/mL
    • Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study
    • Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study for at least 1 year.

Életkor

  • History of malignancy or treatment for a malignancy within the past 3 years that is associated with a life expectancy <5 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin).

Egyéb

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Phase I Treatment
  • Pregnancy or lactation
  • Inability to practice one form of adequate contraction for females of childbearing potential
  • Evidence of harmful or hazardous drinking as defined as a score >= 8 on the AUDIT questionnaire.
  • Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent >= 10 mg/day).
  • Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alpha-fetoprotein level of greater than 500 mg/mL
  • Pregnancy

A regiszterben nem jelölt feltételek

  • INCLUSION CRITERIA:
    • Phase I Treatment
  • Male or female >= 18 years of age
  • Either treatment naive or experienced defined as failure of a prior course of interferon-based and ribavirin, DAA plus interferon and DAA only
  • Confirmation of chronic HCV infection documented by:
    • A positive HCV RNA or positive HCV genotyping test at least 6-months prior to the Baseline/Day 1 visit
    • A liver biopsy performed prior to screening visit showing evidence of chronic hepatitis.
  • Subjects must have the following laboratory parameters at screening:
    • ALT <= 10 x the upper limit of normal (ULN)
    • AST <= 10 x ULN
    • Total bilirubin <2.5 mg/dL, Direct bilirubin <= 1.5 ULN
    • Platelets >= 50,000 K/mm\^3
    • HbA1c <= 8.5%
    • Hemoglobin >= 10g/dL
    • Albumin >= 3g/dL
    • INR <= 1.5 unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
    • HCV RNA positive at screening.
  • Subjects must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator.
    • Phase II Follow-up
  • Male or female >= 18 years of age.
  • SVR24 following therapy with a direct acting antiviral agent regimen and available liver biopsy performed prior to treatment.
  • Subject must be of generally good health as determined by the Investigator.

Életkor a regiszterben: 18 év – 120 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
National Institutes of Health Clinical CenterBethesdaEgyesült ÁllamokIsmeretlen állapot

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