---
title: An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF
nct_id: NCT00076635
overall_status: TERMINATED
phase: PHASE3
sponsor: InterMune
study_type: INTERVENTIONAL
primary_condition: Idiopathic Pulmonary Fibrosis
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00076635.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00076635"
ct_last_update_post_date: 2007-11-06
last_seen_at: "2026-05-12T06:47:31.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF

**Official Title:** An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis

**NCT ID:** [NCT00076635](https://clinicaltrials.gov/study/NCT00076635)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** program discontinued based on GIPF-007 results
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 91
- **Lead Sponsor:** InterMune
- **Conditions:** Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Disease
- **Start Date:** 2003-11
- **Completion Date:** 2007-04
- **CT.gov Last Update:** 2007-11-06

## Brief Summary

Open-label therapy will be administered to up to 220 patients, following completion of either InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of subcutaneous Interferon gamma-1b. The study duration will be 5 years.

## Detailed Description

Open-label therapy will be administered subcutaneously. Patients enrolled will continue to receive Interferon gamma-1b therapy three times per week and will be evaluated at 6-week intervals. Patients not taking Interferon gamma-1b at enrollment will re-initiate therapy with subcutaneous Interferon gamma-1b under a dose-escalation scheme, reaching full dose after 2 weeks.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion criteria:

* Enrollment in Protocol GIPF 002 Part B or GIPF-004
* Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004
* Able to understand and sign a written informed consent form and comply with the requirements of the study

Exclusion criteria:

* pregnancy or lactation
* lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment regimens
* if Principal Investigator deems patient is unsuitable for study
```

## Interventions

- **Interferon gamma-1b** (DRUG) — 200 mcg, SQ, 3x per week

## Primary Outcomes

- **All adverse events up to the end of study** _(time frame: 3.5 years)_
- **Survival status at end of study** _(time frame: 3.5 years)_
- **Serum antibodies to Interferon gamma-1b after the last injection.** _(time frame: 3.5 years)_

## Locations (1)

- Intermune Inc, Brisbane, California, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.intermune inc|brisbane|california|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00076635.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00076635*  
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