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Interferon
Peginterferon Lambda + Lonafarnib/Ritonavir for Hepatitis D
Phase 2
Waitlist Available
Led By Christopher Koh, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
Study Summary
This trial tests 3 drugs to treat chronic hepatitis D in people 18+; participants attend stays of 3-5 days & have tests/scans. Take drugs 48 weeks; have 15 outpatient visits, then 3-day clinic stay 6 months after.
Who is the study for?
Adults over 18 with chronic hepatitis D, who have detectable HDV RNA levels and are on HBV suppression medication (Tenofovir or Entecavir) for at least 12 weeks. Participants must be able to take oral and injected meds, not have serious heart issues or liver disease complications, use effective contraception if of reproductive potential, and not be pregnant or abusing substances.Check my eligibility
What is being tested?
The trial is testing a combination therapy for chronic hepatitis D using three drugs: Peginterferon Lambda (injected weekly), Lonafarnib and Ritonavir (tablets taken twice daily). The treatment lasts for 48 weeks with follow-up visits extending up to about two years including inpatient stays.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site from Peginterferon Lambda, gastrointestinal issues from Lonafarnib tablets, and possible interactions leading to increased drug levels due to Ritonavir's effect on liver metabolism.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The goal of this study is to assess the therapeutic response to 48 weeks of treatment with peginterferon lambda and lonafarnib boosted with ritonavir in patients with chronic hepatitis D.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Peginterferon LambdaExperimental Treatment1 Intervention
A weekly subcutaneous injection of peginterferon lambda at a dose of 180 mcg and an oral twice daily dosing of Lonafarnib at 50mg boosted with twice daily Ritonavir at 100mg for 48 weeks. Following 48 weeks of treatment the subjects will be monitored for outcomes during an additional 6-month time period.
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,358 Previous Clinical Trials
4,315,211 Total Patients Enrolled
Christopher Koh, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe liver disease with specific blood test results and symptoms.I have a major illness besides liver disease.I am currently taking statin medication.I was diagnosed with cancer within the last five years.I haven't taken any immunosuppressive drugs in the last 2 months.I have been on Tenofovir or Entecavir for HBV for over 12 weeks with controlled virus levels.I am not taking any strong or moderate drugs that affect liver enzymes.I have been diagnosed with liver cancer.I haven't taken lonafarnib or pegylated interferon in the last 6 months.I am 18 years old or older.I am not taking any medications that could interact with the trial treatment.I cannot take medications by mouth or injection.I have another liver condition besides viral hepatitis.I have had pancreatitis not caused by gallstones.I am willing and available to follow the study's treatment plan and procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Peginterferon Lambda
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research afford access to those above a certain age?
"The age range for this particular trial is 18 to 120, although there are 22 trials catering exclusively to minors and 212 specifically targeting elderly individuals."
Answered by AI
Has the United States Food and Drug Administration (FDA) sanctioned Peginterferon Lambda?
"The safety of Peginterferon Lambda is given a score of 2, as this trial is in the second phase and while there have been indications that it may be safe, no studies yet show its efficacy."
Answered by AI
Is enrollment open for participants in this research trial?
"According to the information found on clinicaltrials.gov, this specific trial is not in pursuit of participants presently; nonetheless, there are 253 other medical studies recruiting right now. This experiment was first posted on July 25th 2023 and underwent its most recent update a week prior, on July 19th 2023."
Answered by AI
Is my profile congruent with the criteria for this research experiment?
"To be accepted into this clinical trial, participants must have a chronic case of hepatitis delta and an age between 18-120. This study is currently accepting around 30 candidates total."
Answered by AI
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