CLINICAL TRIALS PROFILE FOR PEGINTRON

All Clinical Trials for PEGINTRON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00018031 ↗	Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2001-06-01	This study will evaluate the safety and effectiveness of combination therapy with peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b. This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher blood concentration and thus maintaining activity against the hepatitis C virus. HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2 1/2-year study. Candidates will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is not available. The liver biopsy is done to determine the severity of liver disease. For this test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is injected into an arm vein, the skin in the area over the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. A chest X-ray, electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening tests, candidates who appear eligible for the study will have a physical examination, medical history and repeat blood tests. Women who can become pregnant will have serial pregnancy tests throughout the study. Patients who meet the study criteria and decide to participate will begin treatment with weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a day by mouth. In addition, patients will continue to take all other medications prescribed by their doctor. Clinic visits will be scheduled as follows: - Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV. - Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests will be done to determine the side effects of treatment and its effect on the HCV infection. - Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients will return to the clinic for a routine test.
NCT00027742 ↗	Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma	Completed	National Cancer Institute (NCI)	Phase 2	2001-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.
NCT00027742 ↗	Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	2001-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.

Clinical Trial Conditions for PEGINTRON

Condition Name

Condition Name for PEGINTRON
Intervention	Trials
Hepatitis C, Chronic	49
Hepatitis C	28
Chronic Hepatitis C	8

Condition MeSH

Condition MeSH for PEGINTRON
Intervention	Trials
Hepatitis	82
Hepatitis C	81
Hepatitis A	76

Clinical Trial Locations for PEGINTRON

Trials by Country

Trials by Country for PEGINTRON
Location	Trials
United States	89
Japan	7
Netherlands	6
France	5
Germany	5

Trials by US State

Trials by US State for PEGINTRON
Location	Trials
Maryland	8
Pennsylvania	7
New York	6
California	5
Texas	5

Clinical Trial Progress for PEGINTRON

Clinical Trial Phase

Clinical Trial Phase for PEGINTRON
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	29
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for PEGINTRON
Clinical Trial Phase	Trials
Completed	79
Terminated	10
Unknown status	8

Clinical Trial Sponsors for PEGINTRON

Sponsor Name

Sponsor Name for PEGINTRON
Sponsor	Trials
Merck Sharp & Dohme Corp.	64
Schering-Plough	6
National Institute of Allergy and Infectious Diseases (NIAID)	5

Sponsor Type

Sponsor Type for PEGINTRON
Sponsor	Trials
Industry	89
Other	60
NIH	8

Clinical Trials Update, Market Analysis, and Projection for PEGINTRON

Last updated: November 1, 2025

Introduction

PEGINTRON, a recombinant interferon alpha-2b product developed by Merck KGaA (marketed in some regions as PegIntron), has been a cornerstone therapy in treating hepatitis C virus (HCV) infections, among other indications. Over recent years, the therapeutic landscape for HCV has shifted dramatically with the advent of direct-acting antivirals (DAAs), affecting PEGINTRON’s market positioning. This article provides a comprehensive update on recent clinical trials involving PEGINTRON, analyzes current market dynamics, and offers projections for its future trajectory within the evolving hepatology space.

Clinical Trials Update

Recent Clinical Investigations

Although the global focus has shifted toward DAAs, PEGINTRON continues to feature in clinical research for specific niches:

• Combination Regimens for HCV: Multiple ongoing trials evaluate PEGINTRON in combination with new-generation DAAs to improve efficacy in difficult-to-treat populations. For example, a Phase 2 trial (NCT04698262) explores PEGINTRON combined with glecaprevir/pibrentasvir in genotype 3 HCV, reflecting efforts to optimize treatment durations and tolerability.

• Use in Hepatocellular Carcinoma (HCC): Trials like NCT04539870 examine PEGINTRON’s immunomodulatory effects to evaluate its potential role as an adjunct in HCC management post-liver transplant, notable given the cytokine’s immune-stimulating properties.

• Emerging Orphan Indications: Exploratory studies investigate PEGINTRON’s efficacy in certain hematological conditions and rare viral infections, though these are at preliminary stages.

Safety and Tolerability

Recent data emphasize ongoing concerns regarding adverse effects, especially flu-like symptoms, cytopenias, and neuropsychiatric effects—consistent with PEGINTRON’s profile. The continued research aims to refine dosing regimens that mitigate tolerability issues, potentially broadening its application scope.

Regulatory Developments

In 2022, the European Medicines Agency (EMA) reaffirmed the approval of PEGINTRON for chronic HCV in specific scenarios but underscored the decline in clinical indications, aligning with the shift toward DAA dominance. No recent approvals or significant modifications to labeling have been reported.

Market Analysis

Historical Market Dynamics

PEGINTRON once commanded a substantial market share in HCV treatment, buoyed by its efficacy in interferon-based therapies prior to 2014. However, the rapid adoption of interferon-free DAA regimens (e.g., sofosbuvir/ledipasvir, glecaprevir/pibrentasvir) led to a historic decline in PEGINTRON prescriptions.

Current Market Position

Today, PEGINTRON’s primary market segments are limited to:

• Special Populations: Patients who are intolerant to DAAs, including those with renal impairment or specific contraindications.
• Region-Specific Usage: In certain countries where access to DAAs remains limited or cost-prohibitive, PEGINTRON retains off-label or prescribed roles.
• Combination with Other Agents: Used adjunctively in research settings, especially for patients with complex viral genotypes or prior treatment failure.

The global hepatitis C market is projected to decrease at a compound annual growth rate (CAGR) of approximately 7.5% through 2028, reflecting the diminishing role of interferons overall [1].

Market Challenges

• Competitiveness of DAAs: DAAs offer high cure rates (>95%), shorter treatment courses, fewer adverse effects, and no need for interferon injections, making PEGINTRON largely obsolete in general practice.
• Pricing Pressure: The patent expiration and generic availability of interferon products further suppress PEGINTRON’s market value.
• Regulatory and Reimbursement Hurdles: Insurers favor newer, more effective therapies, limiting coverage for interferon-based treatments.

Emerging Opportunities

Despite declining global relevance, niche markets and specialized indications may sustain minimal demand, especially in resource-limited settings. For example, in countries where DAAs are unavailable, PEGINTRON may still be utilized, albeit with limited margins.

Market Projection

Short-term Outlook (1-3 years)

• Decline in Usage: Expected continues decline in prescribed volumes, primarily for legacy treatments. Global sales forecast to decrease by approximately 15-20% annually, aligning with the trend in hepatitis C therapy abandonment.
• Regulatory Status and Off-label Use: Potential for minimal growth through off-label applications or repurposing in immunological indications being explored in trials.

Long-term Outlook (3-10 years)

• Market Exit or Niche Stabilization: Given the trajectory, PEGINTRON may gradually phase out from major markets unless new indications emerge. Alternatively, strategic repositioning in niche or orphan conditions could provide limited longevity.
• Potential for Biologic Resale or Licensing: If innovative trials demonstrate immunomodulatory benefits beyond HCV, licensing opportunities might arise, especially in combination therapies.

Economic and Competitive Factors

• Pricing dynamics will likely trend toward minimal margins due to generic competition and decreased demand.
• Regulatory agencies may eventually classify PEGINTRON as a legacy product, further discouraging investment and marketing efforts.

Key Takeaways

• Clinical Pipeline Status: PEGINTRON remains under investigation mainly for niche uses or in combination with emerging antiviral agents, but its role in mainstream hepatitis C therapy has largely diminished.
• Market Decline: The global hepatitis C market’s shift towards DAAs has precipitated an accelerated decline in PEGINTRON’s sales and relevance.
• Future Opportunities: Limited, achievable mainly in resource-constrained regions or as an adjunct in specific clinical trials; significant growth prospects are improbable.
• Strategic Focus: Companies should reassess resource allocation towards innovative immunotherapies or next-generation antivirals rather than maintaining diminished interferon-based products.

Conclusion

PEGINTRON’s future hinges on its potential repositioning within niche markets and ongoing clinical evaluations. While its role in mainstream hepatitis C management has effectively ended, research into immunomodulatory benefits may open new avenues—though these remain speculative. Stakeholders in the pharmaceutical and biotech sectors should monitor emerging trial results and regulatory changes to inform strategic decisions on PEGINTRON’s lifecycle management.

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FAQs

1. Is PEGINTRON still used for hepatitis C treatment?
Yes, but its use has significantly declined globally due to the superior efficacy and tolerability of direct-acting antivirals. It remains in specialty settings or resource-limited regions.

2. Are there new clinical trials involving PEGINTRON?
Yes, ongoing trials focus primarily on combination therapies, immunomodulatory roles, and rare indications, but these are limited in scope.

3. What are the main challenges facing PEGINTRON’s market?
The dominance of DAAs, high adverse effect profile, generic competition, and shifts in treatment guidelines have rendered PEGINTRON largely obsolete in mainstream therapy.

4. Can PEGINTRON be repositioned for other indications?
Potentially, but substantive evidence from clinical trials is required. Currently, its future in other indications remains uncertain and experimental.

5. What is the outlook for PEGINTRON’s commercial viability?
Long-term prospects are limited; unless novel applications are validated, PEGINTRON is expected to phase out of most markets within the next 5-7 years.

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References

[1] Global Hepatitis C Market Report, 2022-2028. MarketWatch.
[2] EMA Approval and Review Documentation. European Medicines Agency.
[3] ClinicalTrials.gov. Dataset of ongoing trials involving PEGINTRON.