NCT01598090 (PEDESTAL) is a Phase 3 clinical trial of Peginterferon Lambda-1a in Hepatitis C Virus, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT01598090?

NCT01598090 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT01598090?

Interventions in NCT01598090: Peginterferon Lambda-1a, Peginterferon Alfa-2a, Ribavirin, Telaprevir.

What condition does NCT01598090 study?

NCT01598090 studies Hepatitis C Virus.

Is NCT01598090 still recruiting?

NCT01598090 is currently completed. Last updated 31 July 2019.

Are results published for NCT01598090?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-07-31 · How we verify

NCT01598090: PEDESTAL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

Completed Phase 3 Results posted Last updated 31 July 2019

What this trial tests

Phase 3 trial testing Peginterferon Lambda-1a in Hepatitis C Virus in 881 participants. Completed in 15 May 2015.

Timeline

14 June 2012

Primary endpoint
4 February 2015

15 May 2015

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	881
Start date	14 June 2012
Primary completion	4 February 2015
Estimated completion	15 May 2015
Sites	104 locations across France, Italy, Russia, Belgium, Austria, United Kingdom, Germany, Israel

Drugs / interventions tested

Peginterferon Lambda-1a — full drug profile →
Peginterferon Alfa-2a (PEGINTERFERON ALFA-2A) — full drug profile →
Ribavirin — full drug profile →
Telaprevir — full drug profile →

Conditions studied

Hepatitis C Virus — all drugs for Hepatitis C Virus →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Eligibility, any sex, with Hepatitis C Virus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A Primary · Assessed at Week 4 and Week 12, week 12 reported

eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL).

Group	Value	95% CI
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	51.9	31.9 – 71.3

Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B Primary · Follow-up Week 12

SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL).

Group	Value	95% CI
Part B: Peginterferon Lambda-1a + RBV + TVR	76.2	72 – 80.3
Part B: Peginterferon Alfa-2a + RBV + TVR	82	76.8 – 87.3

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A Primary · Day 1 of treatment up to Week 48

An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization.

AEs

Group	Value	95% CI
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	26

SAEs

Group	Value	95% CI
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	6

Drug related AEs

Group	Value	95% CI
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	12

Discontinuation due to AEs

Group	Value	95% CI
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	2

Death

Group	Value	95% CI
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	0

Dose reductions - Lambda

Group	Value	95% CI
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	3

Dose reductions - RBV

Group	Value	95% CI
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	7

Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A Secondary · Follow-up Week 12

SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection \~ 10 IU/mL).

Group	Value	95% CI
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	48.1	28.7 – 68.1

Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A Secondary · Follow up week 24

SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection \~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.

Group	Value	95% CI
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	40.7	22.4 – 61.2

Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B Secondary · Follow-up Week 12

Group	Value	95% CI
Part B: Peginterferon Lambda-1a + RBV + TVR	73.6	68.7 – 78.5
Part B: Peginterferon Alfa-2a + RBV + TVR	81.9	75.9 – 88

Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B Secondary · After Day 1 of treatment up to Week 48

Cytopenic abnormalities included anemia defined as hemoglobin \<10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) \<750 cubic millimetre (mm\^3); thrombocytopenia defined as platelets \<50,000 mm\^3.

Group	Value	95% CI
Part B: Peginterferon Lambda-1a + RBV + TVR	11.7	8.6 – 14.8
Part B: Peginterferon Alfa-2a + RBV + TVR	55.8	49 – 62.6

Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B Secondary · Week 4 and Week 12

Group	Value	95% CI
Part B: Peginterferon Lambda-1a + RBV + TVR	64	59.3 – 68.6
Part B: Peginterferon Alfa-2a + RBV + TVR	70.9	64.7 – 77.1

Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B Secondary · After Day 1 of treatment up to Week 48

Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.

Flu-Like Symptoms

Group	Value	95% CI
Part B: Peginterferon Lambda-1a + RBV + TVR	14.4	11 – 17.7
Part B: Peginterferon Alfa-2a + RBV + TVR	36.4	29.8 – 43

Musculoskeletal symptoms

Group	Value	95% CI
Part B: Peginterferon Lambda-1a + RBV + TVR	21.4	17.4 – 25.4
Part B: Peginterferon Alfa-2a + RBV + TVR	30.6	24.3 – 36.9

Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B Secondary · Follow-up Week 24

Group	Value	95% CI
Part B: Peginterferon Lambda-1a + RBV + TVR	83	78 – 87.9
Part B: Peginterferon Alfa-2a + RBV + TVR	87	80.7 – 93.4

Percentage of Participants With Rash Secondary · After Day 1 of treatment up to Week 48

All skin reactions involving rash or rash-like events that occurred on treatment were reported.

Group	Value	95% CI
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	63
Part B: Peginterferon Lambda-1a + RBV + TVR	36.3
Part B: Peginterferon Alfa-2a + RBV + TVR	38.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 of treatment up to Week 48. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)

Serious: 6/27 (22%)

Deaths: 0/27

Part B: Peginterferon Lambda-1a + RBV + TVR

Serious: 43/411 (10%)

Deaths: 1/411

Part B: Peginterferon Alfa-2a + RBV + TVR

Serious: 20/206 (10%)

Deaths: 1/206

Serious adverse events (41 terms)

Reaction	System	Part A: Peginterferon Lamb…	Part B: Peginterferon Lamb…	Part B: Peginterferon Alfa…
Jaundice	Hepatobiliary disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Drug-induced liver injury	Hepatobiliary disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Ocular icterus	Eye disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—
Hepatotoxicity	Hepatobiliary disorders	—	—	—
Hypertransaminasaemia	Hepatobiliary disorders	—	—	—
Jaundice cholestatic	Hepatobiliary disorders	—	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Strangulated hernia	General disorders	—	—	—
Substance-induced psychotic disorder	Psychiatric disorders	—	—	—
Overdose	Injury, poisoning and procedural complications	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Blood creatinine increased	Investigations	—	—	—
Electrocardiogram QT prolonged	Investigations	—	—	—
Hepatic enzyme increased	Investigations	—	—	—
Lipase increased	Investigations	—	—	—
Pancreatic enzymes increased	Investigations	—	—	—
Carotid bruit	Investigations	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—

Other adverse events (50 terms — click to expand)

Reaction	System	Part A: Peginterferon Lamb…	Part B: Peginterferon Lamb…	Part B: Peginterferon Alfa…
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Fatigue	General disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Asthenia	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Anal pruritus	Gastrointestinal disorders	—	—	—
Pyrexia	General disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Influenza like illness	General disorders	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
Chills	General disorders	—	—	—
Irritability	Psychiatric disorders	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Anorectal discomfort	Gastrointestinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Amylase increased	Investigations	—	—	—
Blood bilirubin increased	Investigations	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—
Haemorrhoids	Gastrointestinal disorders	—	—	—
Oedema peripheral	General disorders	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—
Anxiety	Psychiatric disorders	—	—	—
Dysgeusia	Nervous system disorders	—	—	—

Most-reported serious reactions: Jaundice, Rash, Drug-induced liver injury, Anaemia, Ocular icterus, Dyspnoea, Pancreatitis acute, Hepatotoxicity.

Data from ClinicalTrials.gov NCT01598090 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting IL-10 Family Cytokines for the Treatment of Human Diseases.
Wang X, Wong K, Ouyang W, Rutz S. · · 2019 · cited 211× · PMID 29038121 · DOI 10.1101/cshperspect.a028548
Hepatitis C virus protease inhibitor-resistance mutations: our experience and review.
Wu S, Kanda T, Nakamoto S, Imazeki F, et al · · 2013 · cited 30× · PMID 24379619 · DOI 10.3748/wjg.v19.i47.8940
A Randomized Study of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a in Combination with Ribavirin and Telaprevir in Patients with Genotype-1 Chronic Hepatitis C.
Flisiak R, Shiffman M, Arenas J, Cheinquer H, et al · · 2016 · cited 8× · PMID 27749900 · DOI 10.1371/journal.pone.0164563
Interferon Lambda: The Next Frontier in Antiviral Therapy?
Chronopoulou S, Tsochantaridis I. · · 2025 · cited 4× · PMID 40573183 · DOI 10.3390/ph18060785

Verify or expand the search:

Other trials of Peginterferon Lambda-1a

Trials testing the same drug.

NCT05070364 — Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV · Phase 3 · unknown
NCT04331899 — Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19 · Phase 2 · completed

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

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NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01598090 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 31 July 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01598090.

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