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Peginterferon Lambda-1a for Hepatitis Delta

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Keck Medical Center of USC, Los Angeles, CAHepatitis DeltaPeginterferon Lambda-1a - Drug
Eligibility
18 - 70
All Sexes
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Study Summary

This trial will compare the safety and efficacy of Peginterferon Lambda to no treatment in patients chronically infected with HDV.

Eligible Conditions
  • Hepatitis Delta

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 72 weeks

72 weeks
Durable Virologic Response

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

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1
S. sonnei 53G
1
huCART19-IL18
1
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Side Effects for

Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
59%Fatigue
48%Pruritus
48%Diarrhoea
44%Rash
41%Nausea
30%Headache
30%Insomnia
19%Rash generalised
19%Depression
19%Vomiting
19%Anorectal discomfort
15%Myalgia
15%Muscle spasms
15%Injection site reaction
15%Anal pruritus
11%Dysgeusia
11%Injection site rash
11%Irritability
11%Influenza like illness
11%Jaundice
11%Anaemia
11%Cough
11%Hyperbilirubinaemia
7%Blood bilirubin increased
7%Bilirubin conjugated increased
7%Pyrexia
7%Pain
7%Dyspepsia
7%Proctalgia
7%Skin exfoliation
7%Oedema peripheral
7%Dyspnoea
7%Dizziness
7%Gastroenteritis
7%Alanine aminotransferase increased
7%Syncope
7%Upper respiratory tract infection
4%Haemorrhoids
4%Arthralgia
4%Hyperuricaemia
4%Dry skin
4%Aspartate aminotransferase increased
4%Alopecia
4%Decreased appetite
4%Chills
4%Overdose
4%Abdominal pain
4%Peptic ulcer haemorrhage
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT01598090) in the Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) ARM group. Side effects include: Fatigue with 59%, Pruritus with 48%, Diarrhoea with 48%, Rash with 44%, Nausea with 41%.

Trial Design

2 Treatment Groups

No treatment for 12 weeks
1 of 2
Peginterferon Lambda for 48 weeks
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Peginterferon Lambda-1a · No Placebo Group · Phase 3

Peginterferon Lambda for 48 weeks
Drug
Experimental Group · 1 Intervention: Peginterferon Lambda-1a · Intervention Types: Drug
No treatment for 12 weeksNoIntervention Group · 1 Intervention: No treatment for 12 weeks · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peginterferon lambda-1a
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 72 weeks

Who is running the clinical trial?

Eiger BioPharmaceuticalsLead Sponsor
21 Previous Clinical Trials
7,140 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 5 Total Inclusion Criteria

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References

Frequently Asked Questions

What is the maximum quota for enrollees in this trial?

"The listing on clinicaltrials.gov verifies that this trial is open for enrollment and actively recruiting patients. The trial was first posted on December 21st, 2021 and last updated November 3rd, 2022. There are 9 different enrolment sites across the country looking for a total of 150 participants." - Anonymous Online Contributor

Unverified Answer

In how many hospitals will this study take place?

"Currently, this trial is operational at 9 clinical sites. The locations in and around Los Angeles, San Francisco, and Redwood City as well other cities. To help reduce travel burden for participants, it is best to pick a location that is close to you." - Anonymous Online Contributor

Unverified Answer

Are the patients in this clinical trial all over the age of 18?

"This trial is recruiting patients that meet the following age requirements: 18 years or older, and 70 years or younger." - Anonymous Online Contributor

Unverified Answer

Which type of patient is this trial designed for?

"This study is looking for approximately 150 individuals who have hepatitis delta virus and are between 18-70 years old." - Anonymous Online Contributor

Unverified Answer

Are there significant risks associated with taking Peginterferon Lambda-1a?

"Peginterferon Lambda-1a is a Phase 3 trial drug, which means that while there is data supporting its efficacy, multiple rounds of testing have also verified its safety. Our team has given it a score of 3." - Anonymous Online Contributor

Unverified Answer

Can new participants join this trial right now?

"This clinical trial, which was published on December 21st 2021, is currently looking for participants. The information regarding the study has been edited as recently as November 3rd, 2022." - Anonymous Online Contributor

Unverified Answer

Are there any existing data sets on the efficacy of Peginterferon Lambda-1a?

"Peginterferon Lambda-1a was first researched in 2020 at Soroka UMC. To date, there have been 13 completed trials with 4 more currently underway; a significant portion of these are located in Los Angeles, California." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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