---
title: An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)
nct_id: NCT01861444
overall_status: TERMINATED
sponsor: Hoffmann-La Roche
study_type: OBSERVATIONAL
primary_condition: Hepatitis D, Chronic
countries: Romania
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01861444.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01861444"
ct_last_update_post_date: 2016-11-02
last_seen_at: "2026-05-12T07:22:22.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)

**Official Title:** National, Multicenter, Observational Study Evaluating Prevalence, Virological and Clinical Characteristics of Chronic Hepatitis Delta in Romania and Assess Efficacy of Peg-interferon Alfa-2a Treatment in Patients With Chronic Hepatitis D (CHD)

**NCT ID:** [NCT01861444](https://clinicaltrials.gov/study/NCT01861444)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Terminated due to financial reasons.
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 45
- **Lead Sponsor:** Hoffmann-La Roche
- **Conditions:** Hepatitis D, Chronic
- **Start Date:** 2011-03
- **Completion Date:** 2015-03
- **CT.gov Last Update:** 2016-11-02

## Brief Summary

This prospective, multicenter, observational study will assess the prevalence of chronic hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis D. Eligible patients treated with Pegasys according to current medical practice will be followed until 24 weeks after the end of treatment.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

For epidemiological part of the study:

* Adult patients \>/= 18 years of age
* Positive HBsAg for at least 6 months

For the non-interventional section of the study

* Adult patients, \>/= 18 years of age
* Positive HBsAg for at least 6 months
* Positive anti-delta and positive HDV RNA by PCR
* Elevated serum ALT \>/= 2x ULN

Exclusion Criteria:

Patients with any of the following will not be eligible for treatment with Pegasys:

* History of neurological disease
* History of severe psychiatric disease
* Decompensated diabetes
* History of immunologically mediated disease
* History of severe cardiac disease
* History or other evidence of severe chronic pulmonary disease
* Inadequate hematologic function
```

## Arms

- **Cohort**

## Primary Outcomes

- **Proportion of chronic hepatitis B patients in Romania with chronic hepatitis D infection** _(time frame: approximately 3.5 years)_
- **Response rate: Proportion of patients achieving ALT normalization and HDV RNA negativity 24 weeks after the end of treatment** _(time frame: approximately 3.5 years)_

## Secondary Outcomes

- **Virological characteristics (HBeAg/anti-HBe/HBV DNA/anti-HDV Ab/HDV RNA) of patients with chronic hepatitis D** _(time frame: approximately 3.5 years)_
- **Proportion of chronic hepatitis D patients with liver cirrhosis** _(time frame: approximately 3.5 years)_

## Locations (1)

- Bucharest, Romania

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|bucharest||romania` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01861444.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01861444*  
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