## Protocol Section
### Identification Module
**NCT ID:** NCT00262379

**Brief Title:** Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C

**Official Title:** Multicenter Study, Randomized and Pragmatic, Comparing Two Therapeutic Strategies : Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C and Treated by Combination Therapy Peginterferon Alfa-2a Plus Ribavirin

#### Organization Study ID Info
**ID:** CP 2005-01
#### Organization
**Class:** OTHER_GOV
**Full Name:** University Hospital, Angers
### Status Module
#### Completion Date
**Date:** 2009-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-12-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-12-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-06

**Type:** ACTUAL

#### Start Date
**Date:** 2005-12

**Status Verified Date:** 2014-12

#### Study First Post Date
**Date:** 2005-12-06
**Type:** ESTIMATED
**Study First Submit Date:** 2005-12-05
**Study First Submit QC Date:** 2005-12-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** University Hospital, Angers

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.

**Detailed Description:** Show that the correction of anemia by epoetin beta (NeoRecormon®) able to maintain a optimal dose of ribavirin (Copegus®). The study compares two therapeutic strategies : use or non-use of epoetin beta (NeoRecormon®) in patients infected by chronic hepatitis C and treated by combination therapy Peginterferon alfa-2a (Pegasys®) plus ribavirin (Copegus®). The main judgement criteria are :

* Sustained Viral Response (Week 72)
* Viral Response at the End of Treatment (Week 48)
* Quality of life
* Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods
* Clinical and biological tolerance

### Conditions Module

**Conditions:**

- Chronic Hepatitis C

**Keywords:**

- Chronic hepatitis C

- peginterferon

- ribavirin

- epoetin beta

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 229

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** HCV treatment with peginterferon plus ribavirin during 48 weeks

**Label:** Group A

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** HCV treatment with peginterferon plus ribavirin during 48 weeks plus epoetin beta under anemia conditions

**Intervention Names:**

- Drug: epoetin beta (NeoRecormon®)

**Label:** Groupb

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Groupb

**Description:** • Prescription of the epoetin beta : when blood concentration of hemoglobin is lower or equal to 12 g/dL in male or lower or equal to 11 g/dL in female

**Name:** epoetin beta (NeoRecormon®)

**Other Names:**

- NeoRecormon®

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period

**Measure:** Sustained Viral Response (Week 72)

**Time Frame:** Week 72

#### Secondary Outcomes

**Description:** Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 48

**Measure:** • Viral Response at the End of Treatment (Week 48)

**Time Frame:** Week 48

**Description:** * Questionnaire HQLQ
* Fatigue Severity Scale HQLQ questionnaire and Fatigue Severity Scale

**Measure:** • Quality of life

**Time Frame:** D0, W4, W12, W24, W48, W72

**Description:** • Cumulating dose of ribavirin during following periods D0-W24 and W24-W48

**Measure:** • Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods

**Time Frame:** D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48

**Description:** Up to 72 weeks, includes all serious and other adverse events that newly occurred or worsened after treatment with PegIFNα-2a, ribavirin or epoetin beta

**Measure:** • Clinical and biological tolerance

**Time Frame:** D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W52, W60, W72

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female patients 18 years old or above
* Patient with French social security or other equivalent health assurance
* Patient with informed consent
* Serologic evidence of chronic hepatitis C by detectable anti-HCV antibodies
* Patient infected by HCV genotype 1, 4, 5 or 6
* Compensated liver disease (Child-Pugh ≤ 6)
* Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior the enrollment in the study
* All fertile males and females receiving ribavirin must have effective contraception during treatment and during the 6 following months
* Patient naive of treatment with installation of treatment by investigator following criteria for use Peginterferon alfa-2a (Pegasys) and ribavirin (Copegus)

Exclusion Criteria:

* Women with ongoing pregnancy or breast feeding
* Male partner of pregnancy woman
* Minor
* Major protected by French law for biomedical study
* Co-infection by HBV or HIV
* History or other evidence of decompensated liver disease or Child-Pugh score \> 6
* Clinical or radiological evidence (abdominal ultrasound, CT scan or MRI) of hepatocellular carcinoma
* IFN or ribavirin at any previous time
* Patient who received an erythropoetin within 2 months before inclusion
* History of epilepsy (during the last 6 months)
* Chronic cardiac insufficiency (stage III or IV in classification from the New York Heart Association \[NYHA\])
* Not controlled portal hypertension
* Antecedents or risk of venous thrombosis
* Surgery within 3 months before inclusion
* Serum creatinine level \>15 mg/mL (130µmol/L)
* Deficiency in vitamin B9 and/or B12 (suspected with macrocytosis \> 105 µm3)
* Thrombocytosis (platelets \> 500 000/mm3)
* Chronic inflammatory syndrome (CRP \> 10 mg/L)
* Deficiency not corrected in iron :
* Ferritin blood level \< 10 µg/L Or - Transferrin saturation coefficient \< 20 %
* History of neoplasia (except basocellular epithelioma and cervical cancer)
* Contraindications to use epoetin beta or an excipient from molecule to study (urea, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, benzoic acid, benzyl alcohol)
* Absence of written informed consent
* Exclusion time for another biomedical study
* Patient with blood concentration of hemoglobin lower or equal to 12 g/dL for male or lower or equal to 11 g/dL for female

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aix en Provence

**Country:** France

**Facility:** H Aix en Provence

**Zip:** 13616

**Location 2:**

**City:** Angers

**Country:** France

**Facility:** UH Angers

**Zip:** 49933

**Location 3:**

**City:** Avignon

**Country:** France

**Facility:** H Avignon

**Zip:** 84 902

**Location 4:**

**City:** Bourgoin-Jallieu

**Country:** France

**Facility:** H Bourgoin-Jallieu

**Zip:** 38 317

**Location 5:**

**City:** Brest

**Country:** France

**Facility:** UH Brest

**Zip:** 29 609

**Location 6:**

**City:** Caen

**Country:** France

**Facility:** UH Caen

**Zip:** 14 033

**Location 7:**

**City:** Châteauroux

**Country:** France

**Facility:** H Châteauroux

**Zip:** 36 000

**Location 8:**

**City:** Clermont Ferrand

**Country:** France

**Facility:** UH Clermont Ferrand

**Zip:** 63009

**Location 9:**

**City:** Corbeil-Essonnes

**Country:** France

**Facility:** H Corbeil-Essonnes

**Zip:** 91 106

**Location 10:**

**City:** Creil

**Country:** France

**Facility:** H Creil

**Zip:** 60 100

**Location 11:**

**City:** Créteil

**Country:** France

**Facility:** H Créteil

**Zip:** 94010

**Location 12:**

**City:** Dijon

**Country:** France

**Facility:** UH Dijon

**Zip:** 21 079

**Location 13:**

**City:** Dreux

**Country:** France

**Facility:** H Dreux

**Zip:** 28100

**Location 14:**

**City:** Freyming-Merlebach

**Country:** France

**Facility:** H Freyming-Merlebach

**Zip:** 57 804

**Location 15:**

**City:** Grasse

**Country:** France

**Facility:** H Grasse

**Zip:** 06 130

**Location 16:**

**City:** Grenoble

**Country:** France

**Facility:** UH Grenoble

**Zip:** 38 043

**Location 17:**

**City:** La Roche sur Yon

**Country:** France

**Facility:** H La Roche sur Yon

**Zip:** 85925

**Location 18:**

**City:** Le Mans

**Country:** France

**Facility:** H Le Mans

**Zip:** 72000

**Location 19:**

**City:** Limoges

**Country:** France

**Facility:** UH Limoges

**Zip:** 87042

**Location 20:**

**City:** Lyon

**Country:** France

**Facility:** UH Lyon

**Zip:** 69 288

**Location 21:**

**City:** Marseille

**Country:** France

**Facility:** H Saint-Joseph

**Zip:** 13 285

**Location 22:**

**City:** Montauban

**Country:** France

**Facility:** H Montauban

**Zip:** 82 013

**Location 23:**

**City:** Montpellier

**Country:** France

**Facility:** UH Montpellier

**Zip:** 34 295

**Location 24:**

**City:** Montélimar

**Country:** France

**Facility:** H montélimar

**Zip:** 26 200

**Location 25:**

**City:** Nantes

**Country:** France

**Facility:** UH Nantes

**Zip:** 44 800

**Location 26:**

**City:** Orléans

**Country:** France

**Facility:** H Orléans

**Zip:** 45100

**Location 27:**

**City:** Paris

**Country:** France

**Facility:** H Tenon

**Zip:** 75 020

**Location 28:**

**City:** Paris

**Country:** France

**Facility:** H saint-Antoine

**Zip:** 75 571

**Location 29:**

**City:** Pau

**Country:** France

**Facility:** H Pau

**Zip:** 64 011

**Location 30:**

**City:** Poitiers

**Country:** France

**Facility:** UH Poitiers

**Zip:** 86 020

**Location 31:**

**City:** Rennes

**Country:** France

**Facility:** UH Rennes

**Zip:** 35 043

**Location 32:**

**City:** Rouen

**Country:** France

**Facility:** UH Rouen

**Zip:** 76 031

**Location 33:**

**City:** Saint Laurent du Var

**Country:** France

**Facility:** Arnault Tzanck Institute

**Zip:** 06721

**Location 34:**

**City:** Saint-Dizier

**Country:** France

**Facility:** H Saint-Dizier

**Zip:** 52 115

**Location 35:**

**City:** Toulouse

**Country:** France

**Facility:** UH Toulouse

**Zip:** 31 059

**Location 36:**

**City:** Tourcoing

**Country:** France

**Facility:** H Tourcoing

**Zip:** 59 208

**Location 37:**

**City:** Tours

**Country:** France

**Facility:** UH Tours

**Zip:** 37 170

#### Overall Officials

**Official 1:**

**Affiliation:** UH Angers

**Name:** Françoise Lunel-Fabiani, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018178

- Term: Flaviviridae Infections

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9607

- Name: Hepatitis, Chronic

- Relevance: HIGH

- As Found: Chronic Hepatitis

- ID: M9611

- Name: Hepatitis C

- Relevance: HIGH

- As Found: Hepatitis C

- ID: M21613

- Name: Hepatitis C, Chronic

- Relevance: HIGH

- As Found: Chronic Hepatitis C

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20324

- Name: Flaviviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006526

- Term: Hepatitis C

- ID: D000019698

- Term: Hepatitis C, Chronic

- ID: D000006505

- Term: Hepatitis

- ID: D000006521

- Term: Hepatitis, Chronic

### Intervention Browse Module - Ancestors

- ID: D000006397

- Term: Hematinics

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M207501

- Name: Chrysarobin

- Relevance: LOW

- As Found: Unknown

- ID: M314

- Name: Epoetin Alfa

- Relevance: HIGH

- As Found: Distal

- ID: M15083

- Name: Ribavirin

- Relevance: LOW

- As Found: Unknown

- ID: M247369

- Name: Peginterferon alfa-2a

- Relevance: LOW

- As Found: Unknown

- ID: M9485

- Name: Hematinics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068817

- Term: Epoetin Alfa

### Misc Info Module

- Version Holder: 2024-05-24
